N/A
N=247
Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03089125 ↗Enrolled (actual)
247
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Modified Medical Research Council Dyspnea Scale (mMRCDS) — 1.88; 1.55 units on a scale — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dyspnea Intervention (Behavioral); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Medical Research Council Dyspnea Scale (mMRCDS) |
-0.89; -0.95 | 0.710 |
| PRIMARY Cancer Dyspnoea Scale (CDS) |
-2.63; -2.26 | 0.677 |
| SECONDARY Functional Assessment of Cancer Therapy - Lung (FACT-L) |
4.86; 2.91 | 0.330 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale |
-1.00; -0.28 | 0.098 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Depression Subscale |
-0.18; -0.10 | 0.845 |
| SECONDARY Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) |
0.54; 1.28 | 0.837 |
| SECONDARY Activity Level (Objective Measure: Actigraphy) |
45.80; 47.42 | 0.431 |
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).
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03089125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.