Clinical trial NCT05059132: Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
Official title: Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Keywords: Pilot study
Tele-rehabilitation
Remote rehabilitation
Exercise therapy
Aerobic exercise
Physical activity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2021-09-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Difference in change in accelerometry-measured physical activity between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12).
Secondary outcomes:
measure: Difference in change in functional capacity between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
measure: Difference in change in self-reported physical activity between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
measure: Difference in change in control of dyspnea between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
measure: Difference in change in anxiety symptoms between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
measure: Difference in change in sleep quality between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
measure: Difference in change in quality of life between baseline and week 12
timeFrame: Baseline, mid study (week 6), and end of study (week 12)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
References:
citation: 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 therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.