Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

• ClinicalTrials.gov Identifier: NCT03089125
• Recruitment Status: Completed
• First Posted: March 24, 2017
• Last Update Posted: April 26, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Joseph A. Greer, Ph.D., Massachusetts General Hospital

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Behavioral: Dyspnea Intervention; Other: Usual Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Nurse administered dyspnea intervention
• Masking: Single (Outcomes Assessor)
• Masking Description: Research staff collecting patient-reported measures will be blind to study assignment group
• Primary Purpose: Supportive Care
• Official Title: Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
• Actual Study Start Date: May 15, 2017
• Actual Primary Completion Date: October 26, 2022
• Actual Study Completion Date: April 6, 2023

Arms and Interventions

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	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; Other: Usual Care; Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians

Outcome Measures

Primary Outcome Measures :

1. Modified Medical Research Council Dyspnea Scale (MMRCDS) [ Time Frame: 8 weeks ]
   Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks
2. Cancer Dyspnoea Scale (CDS) [ Time Frame: 8 weeks ]
   Compare the change between study groups in the CDS score from baseline to 8 weeks

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Modified Medical Research Council Dyspnea Scale (MMRCDS) [ Time Frame: 24 weeks ]
   Compare changes in the MMRCDS scores between study groups over the 24-week study period
2. Cancer Dyspnoea Scale (CDS) [ Time Frame: 24 weeks ]
   Compare changes in the CDS scores between study groups over the 24-week study period
3. Functional Assessment of Cancer Treatment - Lung (FACT-L) [ Time Frame: 24 weeks ]
   Compare changes in the FACT-L scores between study groups over the 24-week study period
4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 24 weeks ]
   Compare changes in anxiety and depression symptoms between study groups over the 24-week study period
5. Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) [ Time Frame: 24 weeks ]
   Compare changes in self-reported leisure time physical activity score between study groups over the 24-week study period
6. Examine potential mediators of intervention effects on patient-reported outcomes [ Time Frame: 24 weeks ]
   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)
7. Examine potential moderators of intervention effects on dyspnea [ Time Frame: 24 weeks ]
   Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors
8. Health service utilization [ Time Frame: 24 weeks ]
   Examine differences between study groups in rates of emergency department and hospitalizations

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Joseph Greer, PhD; Massachusetts General Hospital

More Information

• Responsible Party: Joseph A. Greer, Ph.D., Associate Professor of Psychology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03089125
• Other Study ID Numbers: 16-476
• First Posted: March 24, 2017
• Last Update Posted: April 26, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph A. Greer, Ph.D., Massachusetts General Hospital:

Lung Cancer

Additional relevant MeSH terms:

Lung Neoplasms; Dyspnea; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory