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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 DateFebruary 2, 2017
Start DateMay 2011
Actual Primary Completion DateApril 2016
Primary Outcome Measures

Functional Assessment of Cancer Therapy (Quality of life measure) [Time Frame: change from baseline to 12 weeks]

Secondary Outcome Measures

Functional Assessment of Cancer Therapy (Quality of life measure) [Time Frame: change from baseline over 24 weeks]

Hospital Anxiety and Depression Scale (Mood) [Time Frame: baseline, 12 and 24 weeks]

Prognostic Understanding [Time Frame: baseiline, 12 and 24 weeks]

Family Caregiver Quality of Life (SF-36) [Time Frame: baseline, 12 and 24 weeks]

Family Caregiver Hospital Anxiety and Depression Scale (Mood) [Time Frame: baseline,12 and 24 weeks]

Family Caregiver Prognostic Understanding [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: baseline, 12 and 24 weeks]

Family Caregiver Quality of Life (SF-36) [Time Frame: 24 weeks]

FACT-Lung [Time Frame: 12 and 24 weeks]

FACT-hepatobiliary and FACT-espophageal [Time Frame: 12 and 24 weeks]

Descriptive Information
PhasePhase 3
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 DateFebruary 2017
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

Yes   No

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