Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
Completed · Not applicable
Conditions studied: Lung Neoplasm
In brief
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. The specific aims and hypotheses are: Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40). Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program. Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events. Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40). Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including: 1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
Key facts
- Study ID
- NCT05059132
- Run by
- Kaiser Permanente
- People needed
- 31
- Starts
- 2022-01-10
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2023-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- history of stage I-IIIA lung cancer;
- completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;
- access to a mobile phone or personal computer with internet access;
- willingness to wear activity trackers
You may not qualify if…
- dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;
- acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;
- spontaneous pneumothorax in past 12 months;
- Parkinson's disease;
- multiple sclerosis;
- amyotrophic lateral sclerosis;
- additional movement/gait disorders that may be identified by chart review
Where it is running
- Kaiser Permanente Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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