CompletedNot applicableNCT05059132
Official study title

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

Study 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).

Ask AI to explain this study
Start here

Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedTele-rehabilitation and Education only

The study team can explain what participation involves.

Who it may be forEarly-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 13, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Kaiser Permanente

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Kaiser Permanente
Interventions being studied
Behavioral: Tele-rehabilitation; Other: Education only
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Kaiser Permanente ColoradoAurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2023. Always confirm current availability with the study team.

View original record ↗