Recruiting
Phase 2

Pulmonary Rehabilitation

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07104630

Conditions

Non-small Cell Lung Cancer Stage III

Non-small Cell Lung Cancer Stage IV

Non-small Cell Lung Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulmonary Rehabilitation (PR)

No intervention: Usual care

Study Details

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.

Conditions

Non-small Cell Lung Cancer Stage III

Non-small Cell Lung Cancer Stage IV

Non-small Cell Lung Cancer

Lung Cancer

Study ID

NCT07104630

Start date

Mar 16, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 exclusion criteria:

  • Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy
  • Uncontrolled arrhythmias; individuals with rate-controlled atrial fibrillation for > 1 month prior to start of radiation therapy may be eligible
  • Syncope
  • Acute myocarditis, pericarditis, or endocarditis
  • Acute pulmonary embolus or pulmonary infarction within the last 3 months
  • Acute thrombosis of lower extremities within the last 3 months
  • Suspected dissecting aneurysm
  • Pulmonary edema
  • Respiratory failure
  • Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pulmonary Rehabilitation (PR)

active comparator: Usual care

no intervention: Qualitative interviews

A subset of PR participants, a subset of participants who decline the randomized portion of the study, and a subset of medical care providers will participate in qualitative interviews to assess attitudes and barriers to PR.

Interventions

Pulmonary Rehabilitation (PR)

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.

No intervention: Usual care

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.

Primary outcome measure

  • Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT) [ Time Frame: Baseline, 8 weeks ]
  • Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS) [ Time Frame: Baseline, 8 weeks ]
  • Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30 [ Time Frame: Baseline, 8 weeks ]
  • Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29 [ Time Frame: Baseline, 8 weeks ]
  • 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). [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Melinda Hsu, MD, MS

216-286-6505Melinda.hsu@uhhospitals.org

Peronne Joseph

216-844-8573Peronne.Joseph@uhhospitals.org

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Melinda Hsu, MD, MS

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Pulmonary Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-04-13.