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Pulmonary Rehabilitation in Advanced Lung Cancer Survivors

Pulmonary Rehabilitation in Advanced Lung Cancer Survivors

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07104630
Enrollment
85
Registered
2025-08-05
Start date
2026-03-16
Completion date
2028-12-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage IV

Keywords

Pulmonary Rehabilitation

Brief summary

This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms. This study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath. The other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.

Detailed description

Lung cancer (LC) is the second most common cancer in the world, (1) and the third most common cancer in the United States of America (USA) (2). Because more lung cancer screenings are being done (3-5) and because there have been advances in treatments, people will all stages of LC are living longer, including those with advanced LC. Research has shown that fatigue and breathing issues are commonly experienced by LCS (6). These symptoms can hurt the long-term health and quality of life of LCS (6-8). Currently, there are not many interventions that are used to help these symptoms for LCS. For people with non-cancer-related respiratory disease, like chronic obstructive pulmonary disease (COPD), a type of supportive treatment called pulmonary rehabilitation (PR) can improve symptoms like difficulty breathing, fatigue, difficulty exercising, and health-related quality of life (9-11). PR is a holistic treatment plan that includes a full assessment and is then personalized to fit each person's needs. This could include things like exercise training, education, and behavior change (12). PR is considered standard-of-care for people with COPD (13). PR includes physical activity, which is something that is encouraged in all cancer survivors. There is not much research that talks about the barriers to physical activity in survivors of lung cancer, although fatigue may be one of the most significant ones (14). Doctors may also not feel comfortable encouraging physical activities in people with lung cancer due to concerns about the safety and feasibility in exercise in people with lung cancer (15). However, PR is safe and effective in people with chronic pulmonary conditions, with well-established pathways and programs for these people. As stated above, LCS have persistent fatigue and difficulty breathing, which is often worse in people who have metastatic LC. There is limited, high-quality evidence supporting interventions designed specifically for LCS with advanced disease. PR is potentially a safe and available intervention to improve functional status in LCS with early stage disease, and more research is needed to understand its impact on LCS with metastatic NSCLC treated with modern therapies.

Interventions

Participants will complete an 8-week course of PR, administered by certified respiratory therapists. For each week of the course, participants will attend two PR sessions. Each session will review topics such as physical function, nutrition, and psychosocial health. Participants will also be given an "exercise prescription" to complete throughout the 8-week course. The "exercise prescription" will include individualized cardiopulmonary activities.

Participants will receive standard-of-care, publicly available education on Nutrition and Cancer Survivors and Physical Activity and Cancer Survivors published by the American Institute for Cancer Research.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants will be randomized between the PR arm and the usual care arm. Qualitative interviews will be conducted separately and include participants in the PR arm, participants who declined the randomized portion of the study, and medical care providers.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent * Adults ≥ 18 years of age * ECOG performance status ≤ 3 * Clinical stability: defined as no clinical/radiographic progression within the last three months * Self-reported dyspnea, defined as score ≥ 2 on the modified Medical Research Council (mMRC) Dyspnea Scale * Participants must be fluent in written and spoken English

Exclusion criteria

* Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded * Participants have evidence of clinical and/or radiographic progression * Mental impairment leading to inability to complete study requirements * High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7) * Any of the following cardiac

Design outcomes

Primary

MeasureTime frameDescription
Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)Baseline, 8 weeksThe 6MWT measures the distance (in meters) that a person can walk in 6 minutes, with higher values indicating greater functional capacity
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS)Baseline, 8 weeksThe MBS is a 1-question scale that is asked after the 6MWT, where participants rank their dyspnea (difficulty breathing) on a scale of 1-10, with greater values indicating greater difficulty.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30Baseline, 8 weeksThe EORTC QLQ-C30 is a 30-question questionnaire that captures functional, symptom, global health status, and QoL domains. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate lower quality of life.
Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29Baseline, 8 weeksThe EORTC QLQ-LC29 is a 29-question questionnaire that captures lung cancer-related symptoms and treatment side effects. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate greater symptoms and side effects.
Change in quantity of cancer-related adverse events (AEs), as measured by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Baseline, 8 weeks

Secondary

MeasureTime frameDescription
Participants' barriers to pulmonary rehabilitation in LCS with advanced NSCLC, as measured by thematic findings from qualitative interviewsOne-time interview between month 6 and 30Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.
Thoracic oncology providers' barriers to referral to pulmonary rehabilitation, as measured by thematic findings from qualitative interviewsOne-time interview between month 6 and 30Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.

Countries

United States

Contacts

CONTACTMelinda Hsu, MD, MS
Melinda.hsu@uhhospitals.org216-286-6505
CONTACTPeronne Joseph
Peronne.Joseph@uhhospitals.org216-844-8573
PRINCIPAL_INVESTIGATORMelinda Hsu, MD, MS

Case Comprehensive Cancer Center, University Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026