Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study

Kaiser Permanente

Status: Completed

Conditions: Lung Neoplasm

Treatments: Other: Education only; Behavioral: Tele-rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05059132

LCD-820773

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Tele-rehabilitation

Experimental group

Description:

Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.

Treatment:

Behavioral: Tele-rehabilitation

Education only

Active Comparator group

Description:

Participants in the education arm will receive educational materials only, delivered through telecommunication messages.

Treatment:

Other: Education only