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Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

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: NCT01401907
Recruitment Status : Active, not recruiting
First Posted : July 25, 2011
Results First Posted : July 13, 2017
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Non-small Cell Lung Cancer
Small Cell Lung Cancer
Mesothelioma
Esophageal Cancer
Gastric Cancer
Liver Cancer
Pancreatic Cancer
Intervention Other: early palliative care
Enrollment 350
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Palliative Care Standard of Care
Hide Arm/Group Description

Subjects receive standard of care with early palliative care.

early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.

Subjects receives standard of care
Period Title: Overall Study
Started 175 175
12 Week Outcomes 148 153
Completed [1] 118 124
Not Completed 57 51
[1]
24 week outcomes
Arm/Group Title Early Palliative Care Standard of Care Total
Hide Arm/Group Description

Subjects receive standard of care with early palliative care.

early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.

Subjects receives standard of care Total of all reporting groups
Overall Number of Baseline Participants 175 175 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 175 participants 350 participants
65.64  (11.26) 64.03  (10.46) 64.85  (10.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Female
84
  48.0%
77
  44.0%
161
  46.0%
Male
91
  52.0%
98
  56.0%
189
  54.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Hispanic or Latino
7
   4.0%
2
   1.1%
9
   2.6%
Not Hispanic or Latino
168
  96.0%
173
  98.9%
341
  97.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
American Indian or Alaska Native
4
   2.3%
0
   0.0%
4
   1.1%
Asian
5
   2.9%
3
   1.7%
8
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   3.4%
4
   2.3%
10
   2.9%
White
156
  89.1%
167
  95.4%
323
  92.3%
More than one race
2
   1.1%
0
   0.0%
2
   0.6%
Unknown or Not Reported
2
   1.1%
1
   0.6%
3
   0.9%
1.Primary Outcome
Title Functional Assessment of Cancer Therapy (Quality of Life Measure)
Hide Description The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Palliative Care Standard of Care
Hide Arm/Group Description:

Subjects receive standard of care with early palliative care.

early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.

Subjects receives standard of care
Overall Number of Participants Analyzed 148 153
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
81.10
(78.11 to 82.08)
77.70
(75.77 to 79.63)
2.Secondary Outcome
Title Functional Assessment of Cancer Therapy (Quality of Life Measure)
Hide Description The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)
Arm/Group Title Early Palliative Care Standard of Care
Hide Arm/Group Description:

Subjects receive standard of care with early palliative care.

early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.

Subjects receives standard of care
Overall Number of Participants Analyzed 118 124
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
81.26
(78.89 to 83.63)
75.90
(73.59 to 78.21)
3.Secondary Outcome
Title Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
Hide Description The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.
Time Frame Week-12 and Week-24
Hide Outcome Measure Data
Hide Analysis Population Description
The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.
Arm/Group Title Early Palliative Care Standard Oncology Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 138 141
Measure Type: Count of Participants
Unit of Measure: Participants
Week-12 Number Analyzed 138 participants 141 participants
29
  21.0%
32
  22.7%
Week-24 Number Analyzed 118 participants 122 participants
24
  20.3%
32
  26.2%
4.Secondary Outcome
Title Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
Hide Description We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.
Time Frame Week12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart.
Arm/Group Title Early Palliative Care Standard Oncology Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 143 145
Measure Type: Count of Participants
Unit of Measure: Participants
Goal Cure Week-12 Number Analyzed 143 participants 145 participants
41
  28.7%
50
  34.5%
Goal Cure Week-24 Number Analyzed 115 participants 116 participants
37
  32.2%
32
  27.6%
5.Secondary Outcome
Title Family Caregiver Quality of Life as Measured by the SF-36
Hide Description The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
Time Frame Week-12 and Week-24
Hide Outcome Measure Data
Hide Analysis Population Description
Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.
Arm/Group Title Early Palliative Care Standard Oncology Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 119
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
SF36 PCS Week-12 Number Analyzed 110 participants 119 participants
52.94
(51.30 to 54.59)
51.40
(49.83 to 52.98)
SF36 MCS Week-12 Number Analyzed 110 participants 119 participants
47.00
(45.26 to 48.74)
45.92
(44.25 to 47.59)
SF36 PCS Week-24 Number Analyzed 89 participants 94 participants
52.71
(51.02 to 54.40)
53.22
(51.58 to 54.86)
SF36 MCS Week-24 Number Analyzed 89 participants 94 participants
46.21
(44.09 to 48.33)
45.59
(44.09 to 48.33)
6.Secondary Outcome
Title Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
Hide Description We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.
Arm/Group Title Early Palliative Care Standard Oncology Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 119
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
HADS-Total Week-12 Number Analyzed 110 participants 119 participants
9.02
(8.09 to 9.96)
10.48
(9.58 to 11.38)
HADS-Total Week-24 Number Analyzed 89 participants 94 participants
9.82
(8.65 to 10.99)
10.72
(8.65 to 10.99)
7.Secondary Outcome
Title Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
Hide Description We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.
Time Frame 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow.
Arm/Group Title Early Palliative Care Standard Oncology Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 106 113
Measure Type: Count of Participants
Unit of Measure: Participants
Goal Cure Week-12 Number Analyzed 106 participants 113 participants
34
  32.1%
40
  35.4%
Goal Cure Week-24 Number Analyzed 85 participants 89 participants
19
  22.4%
29
  32.6%
8.Secondary Outcome
Title Resource Utilization at the End of Life (EOL)
Hide Description chemotherapy utilization at the EOL hospice utilization (enrollment rate and length of stay)
Time Frame study participants will be followed until death or for a minimum of 2 years after enrollment
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Health Care Costs
Hide Description [Not Specified]
Time Frame study participants will be followed until death or for a minimum of 2 years after enrollment
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Code Status Documentation
Hide Description examine rates and timing of code status documentation
Time Frame study participants will be followed until death or for a minimum of 2 years after enrollment
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Coping (Brief Cope)
Hide Description compare coping between study arms
Time Frame Week-12 and Week-24
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Additional Resource Utilization
Hide Description hospital admissions, hospice utilization emergency room admissions intensive care unit admissions resuscitation attempt
Time Frame from date of randomization until date of death, assessed up to 3 years
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Survival
Hide Description [Not Specified]
Time Frame from date of randomization until date of death, assessed up to 3 years
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description no AE from this non-medication/treatment study
 
Arm/Group Title Early Palliative Care Standard of Care
Hide Arm/Group Description

Subjects receive standard of care with early palliative care.

early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care.

Subjects receives standard of care
All-Cause Mortality
Early Palliative Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   27/175 (15.43%)   32/175 (18.29%) 
Hide Serious Adverse Events
Early Palliative Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   0/175 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Palliative Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   0/175 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Temel MD
Organization: MGH
Phone: 617-724-4000
EMail: jtemel@partners.org
Layout table for additonal information
Responsible Party: Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01401907    
Other Study ID Numbers: 10-434
First Submitted: July 20, 2011
First Posted: July 25, 2011
Results First Submitted: February 16, 2017
Results First Posted: July 13, 2017
Last Update Posted: December 27, 2019