Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- Modified Medical Research Council Dyspnea Scale (MMRCDS) [8 weeks]
Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks
- Cancer Dyspnoea Scale (CDS) [8 weeks]
Compare the change between study groups in the CDS score from baseline to 8 weeks
Secondary Outcome Measures
- Functional Assessment of Cancer Treatment - Lung (FACT-L) [8 weeks]
Compare the change between study groups in FACT-L from baseline to 8 weeks
- Hospital Anxiety and Depression Scale (HADS) [8 weeks]
Compare the change between study groups in anxiety and depression symptoms from baseline to 8 weeks
- Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) [8 weeks]
Compare the change between study groups in self-reported leisure time physical activity score from baseline to 8 weeks
- Activity Level (objective measures) [8 weeks]
Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy
Other Outcome Measures
- Modified Medical Research Council Dyspnea Scale (MMRCDS) [24 weeks]
Compare changes in the MMRCDS scores between study groups over the 24-week study period
- Cancer Dyspnoea Scale (CDS) [24 weeks]
Compare changes in the CDS scores between study groups over the 24-week study period
- Functional Assessment of Cancer Treatment - Lung (FACT-L) [24 weeks]
Compare changes in the FACT-L scores between study groups over the 24-week study period
- Hospital Anxiety and Depression Scale (HADS) [24 weeks]
Compare changes in anxiety and depression symptoms between study groups over the 24-week study period
- Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) [24 weeks]
Compare changes in self-reported leisure time physical activity score between study groups over the 24-week study period
- Examine potential mediators of intervention effects on patient-reported outcomes [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)
- Examine potential moderators of intervention effects on dyspnea [24 weeks]
Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors
- Health service utilization [24 weeks]
Examine differences between study groups in rates of emergency department and hospitalizations
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A diagnosis of stage IV NSCLC or extensive stage SCLC
-
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Joseph Greer, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-476