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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
31
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
The education only arm will receive information on the importance of general exercise following lung cancer treatment.
Kaiser Permanente Colorado
Aurora, Colorado, United States
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).
Time frame: Baseline, mid study (week 6), and end of study (week 12).
Difference in change in functional capacity between baseline and week 12
Functional capacity will be measured using the mobile six-minute walk test.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, mid study (week 6), and end of study (week 12)
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