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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059132
Other study ID # LCD-820773
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date December 31, 2022

Study information

Verified date December 2023
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Tele-rehabilitation
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
Other:
Education only
The education only arm will receive information on the importance of general exercise following lung cancer treatment.

Locations

Country Name City State
United States Kaiser Permanente Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente American Lung Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ther — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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