Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
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|ClinicalTrials.gov Identifier: NCT01401907|
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : July 13, 2017
Last Update Posted : September 22, 2020
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||early 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 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||December 2019|
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
- Functional Assessment of Cancer Therapy (Quality of Life Measure) [ Time Frame: 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
- Functional Assessment of Cancer Therapy (Quality of Life Measure) [ Time Frame: 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.
- Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale [ Time Frame: 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.
- Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer [ Time Frame: 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.
- Family Caregiver Quality of Life as Measured by the SF-36 [ Time Frame: 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.
- Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) [ Time Frame: 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
- Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer [ Time Frame: 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.
- Coping (Brief Cope) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401907
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jennifer Temel, MD||Massachusetts General Hospital|