NCT05059132

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

Completed NA Last updated 13 December 2023

What this trial tests

NA trial testing Tele-rehabilitation in Lung Neoplasm in 31 participants. Completed in 31 December 2022.

Timeline

10 January 2022

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	31
Start date	10 January 2022
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Tele-rehabilitation
• Education only

Conditions studied

• Lung Neoplasm — all drugs for Lung Neoplasm →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Lung Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial.
   Ha DM, Comer A, Dollar B, Bedoy R, et al · · 2023 · cited 19× · PMID 37656252 · DOI 10.1007/s00520-023-07999-7
2. Potential Therapeutic Role of Respiratory Muscle Training in Dyspnea Management of Cancer Survivors: A Narrative Review.
   Vainshelboim B, Sardesai SD, Bhammar D. · · 2024 · cited 1× · PMID 38751708 · DOI 10.14740/wjon1781