Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
NCT ID: NCT05059132
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2022-01-10
2022-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Tele-rehabilitation
Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.
Tele-rehabilitation
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
Education only
Participants in the education arm will receive educational materials only, delivered through telecommunication messages.
Education only
The education only arm will receive information on the importance of general exercise following lung cancer treatment.
Interventions
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Tele-rehabilitation
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
Education only
The education only arm will receive information on the importance of general exercise following lung cancer treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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American Lung Association
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Locations
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Kaiser Permanente Colorado
Aurora, Colorado, United States
Countries
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References
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Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.
Other Identifiers
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LCD-820773
Identifier Type: -
Identifier Source: org_study_id