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

Not Applicable

Completed

• Conditions: Lung Neoplasm
• Interventions: Other: Education only; Behavioral: Tele-rehabilitation

• Registration Number: NCT05059132
• Lead Sponsor: Kaiser Permanente

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-28
• Study Start: 2022-01-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education only	Education only	Participants in the education arm will receive educational materials only, delivered through telecommunication messages.
Tele-rehabilitation	Tele-rehabilitation	Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.

Primary Outcome Measures

Name	Time	Method
Difference in change in accelerometry-measured physical activity between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12).	Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).

Secondary Outcome Measures

Name	Time	Method
Difference in change in self-reported physical activity between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form
Difference in change in sleep quality between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Sleep quality will be measured using the Pittsburgh Sleep Quality Index
Difference in change in functional capacity between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Functional capacity will be measured using the mobile six-minute walk test.
Difference in change in quality of life between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Quality of life will be measured using the St. George's Respiratory Questionnaire
Difference in change in control of dyspnea between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire.
Difference in change in anxiety symptoms between baseline and week 12	Baseline, mid study (week 6), and end of study (week 12)	Anxiety symptoms will be measured using the General Anxiety Disorder-7

Trial Locations

Locations (1)

Kaiser Permanente Colorado; 🇺🇸 Aurora, Colorado, United States