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Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

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.

Tracking Information
First Received DateJuly 20, 2011
Last Changed DateApril 15, 2017
Start DateMay 2011
Actual Primary Completion DateApril 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]

Proportion 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]

Proportion 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]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Mesothelioma
  • Esophageal Cancer
  • Gastric Cancer
  • Liver Cancer
  • Pancreatic Cancer
Intervention
  • Other: early palliative care
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment350
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT01401907
Responsible Party,
SponsorMassachusetts General Hospital
Verification DateApril 2017
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