Back to resultsEarly Palliative Care in Advanced Lung and Gastrointestinal Malignancies
Primary Purpose
Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
early palliative care
Sponsored by
About this trial
This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring Palliative care, Lung, Gastric, Liver, Pancreatic, Esophageal, Caregiver
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Palliative Care
Standard of Care
Arm Description
Subjects receive standard of care with early palliative care.
Subjects receives standard of care
Outcomes
Primary Outcome Measures
Functional Assessment of Cancer Therapy (Quality of Life Measure)
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
Functional Assessment of Cancer Therapy (Quality of Life Measure)
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.
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
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.
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
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.
Family Caregiver Quality of Life as Measured by the SF-36
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.
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
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
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
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.
Coping (Brief Cope)
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
Full Information
NCT ID
NCT01401907
First Posted
July 20, 2011
Last Updated
October 9, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01401907
Brief Title
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
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 Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma, Esophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic Cancer
Keywords
Palliative care, Lung, Gastric, Liver, Pancreatic, Esophageal, Caregiver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
early palliative care
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Palliative Care
Arm Type
Experimental
Arm Description
Subjects receive standard of care with early palliative care.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects receives standard of care
Intervention Type
Other
Intervention Name(s)
early palliative care
Intervention Description
patient assigned to the intervention will receive early palliative care along with standard oncology care.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Temel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
will share deidentified data with proper IRB approval
Citations:
PubMed Identifier
29474102
Citation
Hoerger M, Greer JA, Jackson VA, Park ER, Pirl WF, El-Jawahri A, Gallagher ER, Hagan T, Jacobsen J, Perry LM, Temel JS. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018 Apr 10;36(11):1096-1102. doi: 10.1200/JCO.2017.75.6676. Epub 2018 Feb 23.
Results Reference
derived
PubMed Identifier
29140772
Citation
Greer JA, Jacobs JM, El-Jawahri A, Nipp RD, Gallagher ER, Pirl WF, Park ER, Muzikansky A, Jacobsen JC, Jackson VA, Temel JS. Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood. J Clin Oncol. 2018 Jan 1;36(1):53-60. doi: 10.1200/JCO.2017.73.7221. Epub 2017 Nov 15.
Results Reference
derived
Learn more about this trial
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
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