Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01401907
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 103
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer; Small Cell Lung Cancer; Mesothelioma; Esophageal Cancer; Gastric Cancer; Liver Cancer; Pancreatic Cancer	Other: early palliative care	N/A

Detailed Description

Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group.

Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist. They will complete questionnaires at 12 weeks and 24 weeks after enrollment.

Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: early palliative careearly palliative care
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Palliative Care Subjects receive standard of care with early palliative care.	Other: early palliative care; patient assigned to the intervention will receive early palliative care along with standard oncology care.
No Intervention: Standard of Care Subjects receives standard of care

Outcome Measures

Primary Outcome Measures

1. Functional Assessment of Cancer Therapy (Quality of Life Measure) [12 weeks]

   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

Secondary Outcome Measures

1. Functional Assessment of Cancer Therapy (Quality of Life Measure) [24 weeks]

   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.

2. Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale [Week-12 and Week-24]

   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.

3. Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer [Week12 and Week 24]

   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.

4. Family Caregiver Quality of Life as Measured by the SF-36 [Week-12 and Week-24]

   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.

5. Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) [Week 12 and Week 24]

   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

6. Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer [12 and 24 weeks]

   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.

7. Coping (Brief Cope) [Up to week-24]

   compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent

• Informed of metastatic disease within the previous 8 weeks

• No prior therapy for metastatic disease

• Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter

• Relative or friend of patient who will likely accompany the patient to clinic visits

Exclusion Criteria:

• Significant psychiatric or other co-morbid disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01401907
• Other Study ID Numbers: 10-434
• First Posted: Jul 25, 2011
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital: Palliative care; Lung; Gastric; Liver; Pancreatic; Esophageal; Caregiver
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Mesothelioma

Study Results

Participant Flow

Arm/Group Title	Early Palliative Care	Standard of Care
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	118	124
NOT COMPLETED	57	51

Baseline Characteristics

Arm/Group Title	Early Palliative Care	Standard of Care	Total
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 Participants	175	175	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.64 (11.26)	64.03 (10.46)	64.85 (10.88)
Sex: Female, Male (Count of Participants)
Female	84 48%	77 44%	161 46%
Male	91 52%	98 56%	189 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 4%	2 1.1%	9 2.6%
Not Hispanic or Latino	168 96%	173 98.9%	341 97.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 2.3%	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%
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%	2 0.6%
Unknown or Not Reported	2 1.1%	1 0.6%	3 0.9%

Outcome Measures

1. Primary Outcome

Title	Functional Assessment of Cancer Therapy (Quality of Life Measure)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early Palliative Care	Standard of Care
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
Measure Participants	148	153
Mean (95% Confidence Interval) [units on a scale]	81.10	77.70

2. Secondary Outcome

Title	Functional Assessment of Cancer Therapy (Quality of Life Measure)
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

Outcome Measure Data

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
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
Measure Participants	118	124
Mean (95% Confidence Interval) [units on a scale]	81.26	75.90

3. Secondary Outcome

Title	Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	138	141
Week-12	29 16.6%	32 18.3%
Week-24	24 13.7%	32 18.3%

4. Secondary Outcome

Title	Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	143	145
Goal Cure Week-12	41 23.4%	50 28.6%
Goal Cure Week-24	37 21.1%	32 18.3%

5. Secondary Outcome

Title	Family Caregiver Quality of Life as Measured by the SF-36
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	110	119
SF36 PCS Week-12	52.94	51.40
SF36 MCS Week-12	47.00	45.92
SF36 PCS Week-24	52.71	53.22
SF36 MCS Week-24	46.21	45.59

6. Secondary Outcome

Title	Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	110	119
HADS-Total Week-12	9.02	10.48
HADS-Total Week-24	9.82	10.72

7. Secondary Outcome

Title	Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	106	113
Goal Cure Week-12	34 19.4%	40 22.9%
Goal Cure Week-24	19 10.9%	29 16.6%

8. Secondary Outcome

Title	Coping (Brief Cope)
Description	compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping
Time Frame	Up to week-24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early Palliative Care	Standard Oncology Care
Arm/Group Description
Measure Participants	118	124
Mean (95% Confidence Interval) [units on a scale]	0.21	-0.88

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	27/175 (15.4%)		32/175 (18.3%)
Serious Adverse Events
	Early Palliative Care		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/175 (0%)		0/175 (0%)
Other (Not Including Serious) Adverse Events
	Early Palliative Care		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/175 (0%)		0/175 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.