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).
Checked against the public recordLast updated Dec 13, 2023 · Source: ClinicalTrials.gov
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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.