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: ≥ 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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 13, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Kaiser Permanente
- Interventions being studied
- Behavioral: Tele-rehabilitation; Other: Education only
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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;
- Parkinson's disease;
- multiple sclerosis;
- amyotrophic lateral sclerosis;
- additional movement/gait disorders that may be identified by chart review
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Kaiser Permanente ColoradoAurora, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2023. Always confirm current availability with the study team.