Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Lung Cancer Clinical Trial

Official title:

Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089125
• Other study ID #: 16-476
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: April 6, 2023

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 6, 2023
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Medical Research Council Dyspnea Scale (MMRCDS)	Compare changes in the MMRCDS scores between study groups over the 24-week study period	24 weeks
Other	Cancer Dyspnoea Scale (CDS)	Compare changes in the CDS scores between study groups over the 24-week study period	24 weeks
Other	Functional Assessment of Cancer Treatment - Lung (FACT-L)	Compare changes in the FACT-L scores between study groups over the 24-week study period	24 weeks
Other	Hospital Anxiety and Depression Scale (HADS)	Compare changes in anxiety and depression symptoms between study groups over the 24-week study period	24 weeks
Other	Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)	Compare changes in self-reported leisure time physical activity score between study groups over the 24-week study period	24 weeks
Other	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
Other	Examine potential moderators of intervention effects on dyspnea	Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors	24 weeks
Other	Health service utilization	Examine differences between study groups in rates of emergency department and hospitalizations	24 weeks
Primary	Modified Medical Research Council Dyspnea Scale (MMRCDS)	Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks	8 weeks
Primary	Cancer Dyspnoea Scale (CDS)	Compare the change between study groups in the CDS score from baseline to 8 weeks	8 weeks
Secondary	Functional Assessment of Cancer Treatment - Lung (FACT-L)	Compare the change between study groups in FACT-L from baseline to 8 weeks	8 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	Compare the change between study groups in anxiety and depression symptoms from baseline to 8 weeks	8 weeks
Secondary	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
Secondary	Activity Level (objective measures)	Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy	8 weeks