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

Study Overview
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Brief Summary
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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: accelerometry-measured physical activity (primary outcome); and functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).

Official Title
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Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Behavioral: Tele-rehabilitation
* Other: Education only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot, parallel randomized study of an exercise + behavioral support intervention to reduce dyspnea and improve walking behavior among lung cancer survivors following curative intent therapy. Forty participants will be randomized 1:1 to the intervention or control arm, with assessments of feasibility, acceptability, safety, and patient-centered outcomes. The intervention period is 12 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-rehabilitation<br>Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program. | Behavioral: Tele-rehabilitation<br>* The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.<br>|
| Active Comparator: Education only<br>Participants in the education arm will receive educational materials only, delivered through telecommunication messages. | Other: Education only<br>* The education only arm will receive information on the importance of general exercise following lung cancer treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilot study, Tele-rehabilitation, Remote rehabilitation, Exercise therapy, Aerobic exercise, Physical activity