Lung Cancer Clinical Trial
Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
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: â‰¥ 20% eligible patients will enroll; â‰¥75% of participants will achieve â‰¥75% adherence to the tele-rehabilitation program.
Hypothesis 1b: â‰¥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire â‰¥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:
accelerometry-measured physical activity (primary outcome); and
functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
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
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;
amyotrophic lateral sclerosis;
additional movement/gait disorders that may be identified by chart review
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There is 1 Location for this study
Aurora Colorado, 80014, United States
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