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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 351
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy (Quality of Life Measure)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Early Palliative Care
Subjects receive standard of care with early palliative care.
Intervention: early palliative care (Other)
Standard of Care
Subjects receives standard of care
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale(Week-12 and Week-24)
- Coping (Brief Cope)(Up to week-24)
- Functional Assessment of Cancer Therapy (Quality of Life Measure)(24 weeks)
- Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)(Week 12 and Week 24)
- Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer(Week12 and Week 24)
- Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer(12 and 24 weeks)
- Family Caregiver Quality of Life as Measured by the SF-36(Week-12 and Week-24)
Investigators
Jennifer Temel, MD
Principal Investigator
Massachusetts General Hospital