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

NCT05059132 | Completed

• 1 other identifier: LCD-820773
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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. 1.accelerometry-measured physical activity (primary outcome); and
2. 2.functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).

Conditions

Lung Neoplasm

Keywords

Pilot study; Tele-rehabilitation; Remote rehabilitation; Exercise therapy; Aerobic exercise; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Difference in change in functional capacity between baseline and week 12

  Baseline, mid study (week 6), and end of study (week 12)

• Difference in change in self-reported physical activity between baseline and week 12

  Baseline, mid study (week 6), and end of study (week 12)

• Difference in change in control of dyspnea between baseline and week 12

  Baseline, mid study (week 6), and end of study (week 12)

• Difference in change in anxiety symptoms between baseline and week 12

  Baseline, mid study (week 6), and end of study (week 12)

• Difference in change in sleep quality between baseline and week 12

  Baseline, mid study (week 6), and end of study (week 12)

Study Arms (2)

Tele-rehabilitation

EXPERIMENTAL

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

Behavioral: Tele-rehabilitation

Education only

ACTIVE COMPARATOR

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

Other: Education only

Interventions

Tele-rehabilitation BEHAVIORAL

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

Tele-rehabilitation

Education only OTHER

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

Education only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• American Lung Association: collaborator

Study Sites (1)

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Location

Related 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 therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.

  PMID: 37656252 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 28, 2021
• Study Start: January 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)