Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

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).

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Usual Care; Behavioral: Dyspnea Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.	Other: Usual Care; Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
Experimental: 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	Other: Usual Care; Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council Dyspnea Scale (mMRCDS)	Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.	8 weeks
Cancer Dyspnoea Scale (CDS)	Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - Lung (FACT-L)	Compare the difference between study groups in the Functional Assessment of Cancer Therapy - Lung Scale scores at 8 weeks. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life.	8 weeks
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale	Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Anxiety Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms.	8 weeks
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Depression Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms.	8 weeks
Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)	Compare the difference between study groups in the Godin-Shephard Leisure Time Physical Activity Questionnaire scores at 8 weeks. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity.	8 weeks
Activity Level (Objective Measure: Actigraphy)	Compare the difference between study groups in the percentage of time spent immobile but awake over a consecutive three day period per actigraphy at 8 weeks. Scores range from 0% to 100%, with higher scores indicating a greater percentage of time spent immobile while awake over a consecutive three day period.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council Dyspnea Scale (mMRCDS)	Compare the difference between study groups in the estimated slopes of the scores on the Modified Medical Research Council Dyspnea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.	24 weeks
Cancer Dyspnoea Scale (CDS)	Compare the difference between study groups in the estimated slopes of the scores on the Cancer Dyspnoea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.	24 weeks
Functional Assessment of Cancer Therapy - Lung (FACT-L)	Compare the difference between study groups in the estimated slopes of the scores on the Functional Assessment of Cancer Therapy - Lung Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life.	24 weeks
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale	Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Anxiety Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms.	24 weeks
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Depression Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms.	24 weeks
Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)	Compare the difference between study groups in the estimated slopes of the scores on the Godin-Shephard Leisure Time Physical Activity Questionnaire over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity.	24 weeks
Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes	Examine the degree to which intervention effects on patient reported outcomes are mediated by improved mastery in managing breathlessness (as measured by the Chronic Respiratory Disease Questionnaire)	24 weeks
Examine Potential Moderators of Intervention Effects on Dyspnea	Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors	24 weeks
Health Service Utilization	Examine differences between study groups in rates of emergency department and hospitalizations	24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Nursing Research (NINR); Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Joseph Greer, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Signs and Symptoms, Respiratory; Lung Neoplasms; Dyspnea
• Other Study ID Numbers: 16-476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No