Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

early palliative care

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Palliative Care

Subjects receive standard of care with early palliative care.

Group Type EXPERIMENTAL

early palliative care

Intervention Type OTHER

patient assigned to the intervention will receive early palliative care along with standard oncology care.

Standard of Care

Subjects receives standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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early palliative care

patient assigned to the intervention will receive early palliative care along with standard oncology care.

Intervention Type OTHER

Eligibility Criteria

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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