Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Other: Usual CareBehavioral: Dyspnea Intervention
- Registration Number
- NCT03089125
- Lead Sponsor
- Massachusetts General Hospital
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
- 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
- Cognitive or psychiatric conditions prohibiting study consent or participation.
- A treating clinician who reports that the patient is inappropriate for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians. Dyspnea Intervention Usual Care Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness Dyspnea Intervention 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
- Primary Outcome Measures
Name Time Method Modified Medical Research Council Dyspnea Scale (mMRCDS) 8 weeks 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.
Cancer Dyspnoea Scale (CDS) 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Functional Assessment of Cancer Therapy - Lung (FACT-L) 8 weeks 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.
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale 8 weeks 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.
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale 8 weeks 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.
Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) 8 weeks 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.
Activity Level (Objective Measure: Actigraphy) 8 weeks 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.
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States