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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

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: NCT02349412
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : February 28, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Liver Cancer
Anxiety Disorder
Depression
Small Cell Lung Cancer
Extrahepatic Bile Duct Cancer
Malignant Mesothelioma
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Non-small Cell Lung Cancer
Intervention Other: Early palliative care
Enrollment 405
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Period Title: Overall Study
Started 202 203
Completed Week-12 QOL Assessment Measure 92 101
Completed Week-24 QOL Assessment Measure 68 80
Completed 195 196
Not Completed 7 7
Reason Not Completed
Withdrawal by Subject             7             7
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care) Total
Hide Arm/Group Description Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family. Total of all reporting groups
Overall Number of Baseline Participants 195 196 391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 195 participants 196 participants 391 participants
65.5
(35 to 97)
65.0
(34 to 92)
65.2
(34 to 97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
Female
81
  41.5%
89
  45.4%
170
  43.5%
Male
114
  58.5%
107
  54.6%
221
  56.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
American Indian or Alaska Native
2
   1.0%
2
   1.0%
4
   1.0%
Asian
9
   4.6%
6
   3.1%
15
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.0%
2
   0.5%
Black or African American
24
  12.3%
22
  11.2%
46
  11.8%
White
148
  75.9%
155
  79.1%
303
  77.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
   6.2%
9
   4.6%
21
   5.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 195 participants 196 participants 391 participants
195
 100.0%
196
 100.0%
391
 100.0%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
0
47
  24.1%
41
  20.9%
88
  22.5%
1
108
  55.4%
127
  64.8%
235
  60.1%
2
40
  20.5%
28
  14.3%
68
  17.4%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
1.Primary Outcome
Title Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Hide Description Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description:
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Overall Number of Participants Analyzed 92 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.35  (14.7) 0.12  (12.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method ANCOVA
Comments Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.23
Confidence Interval (2-Sided) 95%
-0.67 to 7.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Hide Description Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with available data on the individual study measure at baseline and 24 weeks were included in the analysis.
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description:
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Overall Number of Participants Analyzed 68 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.80  (15.3) 0.69  (13.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method ANCOVA
Comments Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.12
Confidence Interval (2-Sided) 95%
-1.54 to 7.77
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression
Hide Description Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description:
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Overall Number of Participants Analyzed 100 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.54  (4.0) 0.46  (3.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method ANCOVA
Comments Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.94 to 2.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety
Hide Description Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description:
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Overall Number of Participants Analyzed 100 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.13  (2.7) -0.32  (2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method ANCOVA
Comments Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.54 to -0.07
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire
Hide Description Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: "Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?" responses at Week-12 are reported below.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with available data on the individual study measure at week 12 were included in the analysis.
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description:
Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.
Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Overall Number of Participants Analyzed 99 110
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
30
  30.3%
16
  14.5%
No
69
  69.7%
94
  85.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Change in QOL on the SF-36 Over Time
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Rate of Referral, Enrollment and Length of Stay on Hospice
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Location of Death
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Hospital and Intensive Care Unit (ICU) Admissions and Days
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Chemotherapy and Radiation Administration
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Concordance Between Patient and Family Caregiver Report of Prognosis/Curability
Hide Description [Not Specified]
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame Adverse events were not collected for this study.
Adverse Event Reporting Description Adverse events were not collected for this study.
 
Arm/Group Title Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Hide Arm/Group Description Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
All-Cause Mortality
Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 (Early Palliative Care) Arm 2 (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Temel, MD
Organization: Massachusetts General Hospital Cancer Center
Phone: (617) 724-0453
EMail: jtemel@partners.org
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02349412    
Other Study ID Numbers: A221303
U10CA037447 ( U.S. NIH Grant/Contract )
UG1CA189823 ( U.S. NIH Grant/Contract )
NCI-2014-01943 ( Registry Identifier: NCI Clinical Trial Reporting Program Office )
First Submitted: January 23, 2015
First Posted: January 28, 2015
Results First Submitted: February 5, 2019
Results First Posted: February 28, 2019
Last Update Posted: October 16, 2019