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

Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer

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 Overview

• Status: Completed
• Conditions: Lung Neoplasm
• Intervention / Treatment: Behavioral: Tele-rehabilitation; Other: Education only

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: American Lung Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Aerobic exercise; Physical activity; Pilot study; Exercise therapy; Tele-rehabilitation; Remote rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LCD-820773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No