Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2023-04-06

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Nurse administered dyspnea intervention

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Research staff collecting patient-reported measures will be blind to study assignment group

Study Groups

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Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Dyspnea Intervention

Dyspnea intervention will be administered over two sessions

Patients will receive:

* Psychoeducation
* Relaxation training for reducing physiological stress
* Behavioral techniques for managing acute breathlessness

Group Type EXPERIMENTAL

Dyspnea Intervention

Intervention Type BEHAVIORAL

Dyspnea intervention will be administered over two sessions

Patients will receive:

* Psychoeducation
* Relaxation training for reducing physiological stress
* Behavioral techniques for managing acute breathlessness

Usual Care

Intervention Type OTHER

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

Interventions

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Dyspnea Intervention

Dyspnea intervention will be administered over two sessions

Patients will receive:

* Psychoeducation
* Relaxation training for reducing physiological stress
* Behavioral techniques for managing acute breathlessness

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No