Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 1216 for:    "Hodgkin lymphoma"

Therapy for Pediatric Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00145600
Recruitment Status : Active, not recruiting
First Posted : September 5, 2005
Results First Posted : May 7, 2013
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Interventions Drug: 12 Week Stanford V Chemotherapy
Drug: 4 cycles of VAMP chemotherapy
Drug: 2 alternating cycles of VAMP/COP chemotherapy
Drug: 3 alternating cycles of VAMP/COP chemotherapy
Enrollment 296
Recruitment Details 296 patients were enrolled from 5 institutions between March 2000 and May 2011.
Pre-assignment Details  
Arm/Group Title Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Hide Arm/Group Description

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

Period Title: Overall Study
Started 91 46 13 146
Completed 83 36 8 130
Not Completed 8 10 5 16
Reason Not Completed
Death             1             2             2             6
Ineligible             3             0             1             5
Lost to Follow-up             2             6             2             4
Noncompliance             1             0             0             0
Withdrawal by Subject             1             2             0             1
Arm/Group Title Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2 Total
Hide Arm/Group Description

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

Total of all reporting groups
Overall Number of Baseline Participants 91 46 13 146 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 46 participants 13 participants 146 participants 296 participants
<=18 years
84
  92.3%
36
  78.3%
11
  84.6%
122
  83.6%
253
  85.5%
Between 18 and 65 years
7
   7.7%
10
  21.7%
2
  15.4%
24
  16.4%
43
  14.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 46 participants 13 participants 146 participants 296 participants
13.08  (3.91) 15.35  (3.28) 14.85  (3.21) 15.06  (3.37) 14.48  (3.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 46 participants 13 participants 146 participants 296 participants
Female
32
  35.2%
26
  56.5%
5
  38.5%
80
  54.8%
143
  48.3%
Male
59
  64.8%
20
  43.5%
8
  61.5%
66
  45.2%
153
  51.7%
1.Primary Outcome
Title Event-free Survival Probability by Risk Group
Hide Description Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.
Time Frame Median 6.4 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Nine patients were ineligible for analysis.
Arm/Group Title Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Hide Arm/Group Description:

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

Overall Number of Participants Analyzed 88 46 12 141
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of 5 yr. event free survival
0.886
(0.8096 to 0.9624)
0.844
(0.7401 to 0.9479)
0.667
(0.416 to 0.918)
0.788
(0.698 to 0.878)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favorable Risk
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Event-free survival estimat
Estimated Value 0.886
Confidence Interval (2-Sided) 95%
0.8096 to 0.9624
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intermediate Risk
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan Meier event-free survival estimat
Estimated Value 0.844
Confidence Interval (2-Sided) 95%
0.7401 to 0.9479
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unfavorable Risk, Group 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan Meier event-free survival estimat
Estimated Value 0.667
Confidence Interval (2-Sided) 95%
0.416 to 0.918
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Unfavorable Risk, Group 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan Meier event-free survival estimat
Estimated Value 0.788
Confidence Interval (2-Sided) 95%
0.698 to 0.878
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 152 152 145 145 139 139 109 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.2  (21.4) 73.9  (24.5) 72.3  (20.2) 65.4  (21.9) 74.7  (20.9) 66.5  (21) 84.5  (16.6) 78.6  (22.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3097
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0197
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 151 151 146 146 139 139 110 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
68.4  (18.1) 62.3  (20.1) 70.7  (20.5) 64  (18.3) 74.1  (20.4) 65.7  (20.2) 78.5  (21.3) 77.1  (19.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3624
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.52
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 151 151 144 144 138 138 110 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
87.2  (16) 83  (20.2) 87.2  (14.5) 81.4  (17.8) 88.2  (12.9) 82.2  (16.2) 91.5  (13.2) 85.8  (17.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0254
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Correlation Coefficients
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 129 129 114 114 106 106 95 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
69.6  (18) 66.2  (22.1) 67.2  (20.6) 66.7  (21.8) 69  (21.6) 66.7  (21.6) 78.6  (18.3) 76.5  (20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0687
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficient
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9478
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2999
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3121
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.52
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 129 129 114 114 106 106 95 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.7  (13.5) 71.3  (16.4) 75.1  (15) 71.1  (15.3) 77.5  (15.1) 72.3  (15.9) 83.1  (14.7) 80.7  (15.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0282
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1474
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.49
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
Arm/Group Title Patient At Diagnosis (T1) Parent At Diagnosis (T1) Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at Diagnosis (T1).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 129 129 113 113 106 106 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
76.2  (14.9) 72.4  (17.7) 74.2  (15.4) 69.3  (16.2) 77  (15.1) 70.6  (16.1) 84  (13.7) 80.7  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0281
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient At Diagnosis (T1), Parent At Diagnosis (T1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0552
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.54
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 143 143 131 131 106 106
Mean (Standard Deviation)
Unit of Measure: units on a scale
67.7  (25.2) 57.3  (24.6) 69.4  (26.4) 60.2  (25.7) 83.4  (23.4) 77  (23.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxan signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.68
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.50
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 142 142 131 131 101 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
60.7  (22.5) 58.6  (22) 59.7  (24.9) 57.7  (23.8) 75  (22.6) 78.9  (22.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2758
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1731
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0846
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.46
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 142 142 128 128 103 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.3  (27.9) 70.3  (27.9) 73.8  (27.7) 63.2  (29.6) 78.5  (25.4) 72.7  (28.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4263
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0468
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.55
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 140 140 130 130 104 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
84.1  (20.6) 72.8  (25.2) 82.8  (22.7) 71.1  (24.9) 82.1  (23) 77.6  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0704
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0200
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.42
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 141 141 131 131 101 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.5  (24.2) 64.5  (21.3) 64.7  (24.9) 64.7  (23.6) 67.1  (28) 68.6  (25.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7192
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8663
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7626
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.58
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 139 139 126 126 105 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.6  (19.2) 75.7  (19.7) 78.9  (20.2) 74.3  (22.2) 80.8  (20.4) 76.3  (22.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4807
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0824
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0496
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.50
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 143 143 126 126 105 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.5  (23.1) 71.9  (25.9) 77.6  (23.3) 71.2  (26.6) 78.4  (25) 80.5  (22.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0157
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1478
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.56
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 142 142 127 127 105 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.3  (19.5) 73.6  (27.8) 80.6  (19.9) 74.9  (25.2) 83.7  (19.5) 83.1  (20.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0831
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9848
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0974
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.16
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.
Hide Description Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Hide Outcome Measure Data
Hide Analysis Population Description
Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
Arm/Group Title Patient Completion of 2 Cycles of Chemotherapy (T2) Parent Completion of 2 Cycles of Chemotherapy (T2) Patient Completion of 4 Cycles of Chemotherapy (T3) Parent Completion of 4 Cycles of Chemotherapy (T3) Patient 3-6 Months After the Completion of Therapy (T5) Parent 3-6 Months After the Completion of Therapy (T5)
Hide Arm/Group Description:
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
Overall Number of Participants Analyzed 132 132 118 118 91 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
72.4  (14.6) 68.3  (14.7) 72.7  (16.7) 67.6  (16.3) 78.1  (16) 77.6  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patient Completion of 2 Cycles of Chemotherapy (T2), Parent Completion of 2 Cycles of Chemotherapy (T2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patient Completion of 4 Cycles of Chemotherapy (T3), Parent Completion of 4 Cycles of Chemotherapy (T3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8108
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patient 3-6 Months After the Completion of Therapy (T5), Parent 3-6 Months After the Completion of Therapy (T5)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation Coefficients
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation Coefficients
Estimated Value 0.55
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Event-free Survival Probability by Risk Group at 10-year Follow-Up
Hide Description Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.
Time Frame 10-year follow-up after protocol enrollment
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from the date a patient went on study through the completion of therapy. The elapsed timeframe for adverse event collection was eleven years (March, 2000 through May, 2011).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Hide Arm/Group Description

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

All-Cause Mortality
Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/91 (0.00%)      0/46 (0.00%)      0/13 (0.00%)      1/146 (0.68%)    
Vascular disorders         
Thrombosis/thrombus/embolism * 1  0/91 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/146 (0.68%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Favorable Risk Intermediate Risk Unfavorable Risk, Group 1 Unfavorable Risk, Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/88 (61.36%)      39/46 (84.78%)      12/13 (92.31%)      116/146 (79.45%)    
Blood and lymphatic system disorders         
Hemoglobin * 1  0/88 (0.00%)  0 2/46 (4.35%)  3 1/13 (7.69%)  4 52/146 (35.62%)  85
Leukocytes (total WBC) * 1  15/88 (17.05%)  22 24/46 (52.17%)  51 10/13 (76.92%)  42 89/146 (60.96%)  236
Lymphopenia * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 24/146 (16.44%)  66
Neutrophils/granulocytes (ANC/AGC) * 1  53/88 (60.23%)  118 39/46 (84.78%)  98 11/13 (84.62%)  51 101/146 (69.18%)  234
Platelets * 1  0/88 (0.00%)  0 3/46 (6.52%)  5 1/13 (7.69%)  2 0/146 (0.00%)  0
Gastrointestinal disorders         
Constipation * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Mucositis/stomatitis (functional/symptomatic), Oral cavity * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Nausea * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Vomiting * 1  0/88 (0.00%)  0 4/46 (8.70%)  4 1/13 (7.69%)  1 0/146 (0.00%)  0
Infections and infestations         
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  0/88 (0.00%)  0 7/46 (15.22%)  7 2/13 (15.38%)  2 12/146 (8.22%)  13
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Infection with unknown ANC, Blood * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Metabolism and nutrition disorders         
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Bilirubin (hyperbilirubinemia) * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/146 (0.00%)  0
Potassium, serum-low (hypokalemia) * 1  0/88 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 7/146 (4.79%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Monika Metzger, MD
Organization: St. Jude Children's Research Hospital
Phone: 1-866-278-5833
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00145600     History of Changes
Other Study ID Numbers: HOD99
NCI-2011-03721 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: February 12, 2013
Results First Posted: May 7, 2013
Last Update Posted: February 27, 2018