Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether eight weeks of pulmonary rehabilitation, a treatment to help with breathing, can help adults with advanced non-small cell lung cancer breathe and function better. Half will get this treatment, and half will get their usual care. Interviews will also explore what makes it hard for patients to take part in pulmonary rehabilitation.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- A tissue test confirmed stage III or IV non-small cell lung cancer. Your treatment aims to ease symptoms or control the cancer, not cure it.
- You have an ECOG activity score of 3 or less, a measure of how well you can do daily tasks.
- Your cancer has not gotten worse based on symptoms or scans in the past 3 months.
- You report shortness of breath with a score of 2 or higher on the study’s breathing scale.
- You can read, write, and speak English fluently.
Who can't join
- You are getting chemotherapy and radiation together to cure lung cancer that has spread nearby or to only a few other places.
- Your symptoms or scans show that your cancer is getting worse.
- Problems with thinking or memory prevent you from completing study tasks.
- You have a high risk of broken bones or an unstable spine, with a Mirels or SINS score of 7 or higher.
- You have class II, III, or IV heart failure, fainting, or an uncontrolled uneven heartbeat. Atrial fibrillation may be allowed if the heart rate has been controlled for more than 1 month before radiation starts.
- You had a heart attack, unstable chest pain, or a procedure to open heart arteries within 6 months before radiation starts.
- You have sudden inflammation in or around the heart, a suspected tear in a bulging artery, fluid in the lungs, or lungs that cannot support breathing well enough.
- You had a lung blood clot, lung tissue damage from blocked blood flow, or a leg blood clot in the past 3 months; or you have another sudden illness that could limit exercise or get worse with exercise.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
OH
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center · Cleveland, OH 44106Melinda Hsu, MD, MS · Study contactMelinda Hsu, MD, MS · Principal investigatorMore trials in Cleveland