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.
|First Received Date||July 20, 2011|
|Last Changed Date||August 28, 2017|
|Start Date||May 2011|
|Actual Primary Completion Date||April 2016|
|Primary Outcome Measures||
Functional Assessment of Cancer Therapy (Quality of Life Measure) [Time Frame: 12 weeks]
|Secondary Outcome Measures||
Functional Assessment of Cancer Therapy (Quality of Life Measure) [Time Frame: 24 weeks]
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale [Time Frame: 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]
Family Caregiver Quality of Life as Measured by the SF-36 [Time Frame: Week-12 and Week-24]
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) [Time Frame: Week 12 and Week 24]
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer [Time Frame: 12 and 24 weeks]
Resource Utilization at the End of Life (EOL) [Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment]
Health Care Costs [Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment]
Code Status Documentation [Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment]
Coping (Brief Cope) [Time Frame: Week-12 and Week-24]
|Study Arms / Comparison Groups||2 / 0|
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.
|Recruitment Status||Active, not recruiting|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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
- Significant psychiatric or other co-morbid disease
|Sponsor||Massachusetts General Hospital|
|Verification Date||April 2017|