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

Sponsor

Kaiser Permanente (Other)

Overall Status

Recruiting

CT.gov ID

NCT05059132

Collaborator

American Lung Association (Other)

Enrollment

Location

Arms

17.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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:

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasm	Behavioral: Tele-rehabilitation Other: Education only	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Tele-rehabilitation

Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.

Behavioral: Tele-rehabilitation

The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.

Active Comparator: Education only

Participants in the education arm will receive educational materials only, delivered through telecommunication messages.

Other: Education only

The education only arm will receive information on the importance of general exercise following lung cancer treatment.

Outcome Measures

Primary Outcome Measures

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

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 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 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
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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