Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Mass General Brigham

Status: Completed

Conditions: Gastric Cancer; Esophageal Cancer; Small Cell Lung Cancer; Non-small Cell Lung Cancer; Mesothelioma; Liver Cancer; Pancreatic Cancer

Treatments: Other: early palliative care

Study type: Interventional

Funder types: Other

Identifiers

NCT01401907

10-434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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351 participants in 2 patient groups

Early Palliative Care

Experimental group

Description:

Subjects receive standard of care with early palliative care.

Treatment:

Other: early palliative care

Standard of Care

No Intervention group

Description:

Subjects receives standard of care