Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Study Overview
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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).

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.

Official Title
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Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Dyspnea Intervention
* Other: Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Nurse administered dyspnea intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. | Other: Usual Care<br>* Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians<br>|
| Experimental: Dyspnea Intervention<br>Dyspnea intervention will be administered over two sessions Patients will receive: Psychoeducation Relaxation training for reducing physiological stress Behavioral techniques for managing acute breathlessness | Behavioral: Dyspnea Intervention<br>* Dyspnea intervention will be administered over two sessions Patients will receive: Psychoeducation Relaxation training for reducing physiological stress Behavioral techniques for managing acute breathlessness<br>Other: Usual Care<br>* Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council Dyspnea Scale (MMRCDS) | Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks | 8 weeks | 
| Cancer Dyspnoea Scale (CDS) | Compare the change between study groups in the CDS score from baseline to 8 weeks | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Treatment - Lung (FACT-L) | Compare the change between study groups in FACT-L from baseline to 8 weeks | 8 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | Compare the change between study groups in anxiety and depression symptoms from baseline to 8 weeks | 8 weeks | 
| Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) | Compare the change between study groups in self-reported leisure time physical activity score from baseline to 8 weeks | 8 weeks | 
| Activity Level (objective measures) | Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer