Overview

This trial is active, not recruiting.

Conditions non-small cell lung cancer, small cell lung cancer, mesothelioma, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer
Treatment early palliative care
Phase phase 3
Sponsor Massachusetts General Hospital
Start date May 2011
End date December 2017
Trial size 350 participants
Trial identifier NCT01401907, 10-434

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Subjects receive standard of care with early palliative care.
early palliative care
patient assigned to the intervention will receive early palliative care along with standard oncology care.
(No Intervention)
Subjects receives standard of care

Primary Outcomes

Measure
Functional Assessment of Cancer Therapy (Quality of life measure)
time frame: change from baseline to 12 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jennifer Temel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.
Location data was received from the National Cancer Institute and was last updated in September 2016.