Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Mass General Brigham

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Usual Care; Behavioral: Dyspnea Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03089125

16-476

Details and patient eligibility

About

This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).

Full description

Many individuals with advanced lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer.

The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent
• Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of day)
• The ability to read and respond to questions English
• Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
• Age >18 years

Exclusion criteria

• Cognitive or psychiatric conditions prohibiting study consent or participation.
• A treating clinician who reports that the patient is inappropriate for the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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247 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.

Treatment:

Other: Usual Care

Dyspnea Intervention

Experimental group

Description:

Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness

Treatment:

Behavioral: Dyspnea Intervention

Other: Usual Care