Clinical trial · Interventional
Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention: Usual care | Other | — | UNRESOLVED |
| Pulmonary Rehabilitation (PR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pulmonary Rehabilitation (PR)
- interventionNames
- Behavioral: Pulmonary Rehabilitation (PR)
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- interventionNames
- Other: No intervention: Usual care
- type
- NO_INTERVENTION
- label
- Qualitative interviews
- description
- 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.
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDSiegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. PMID 36633525
- BACKGROUNDNational Lung Screening Trial Research Team. Lung Cancer Incidence and Mortality with Extended Follow-up in the National Lung Screening Trial. J Thorac Oncol. 2019 Oct;14(10):1732-1742. doi: 10.1016/j.jtho.2019.05.044. Epub 2019 Jun 28. PMID 31260833
- BACKGROUNDde Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29. PMID 31995683
- BACKGROUNDPastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Jul 1;30(7):1162-1169. doi: 10.1093/annonc/mdz117. PMID 30937431
- BACKGROUNDHsu ML, Guo MZ, Olson S, Eaton C, Boulanger M, Turner M, Miller ME, Nguyen A, Szczepanek K, Shenolikar R, Feliciano JL. Lung Cancer Survivorship: Physical, Social, Emotional, and Medical Needs of NSCLC Survivors. J Natl Compr Canc Netw. 2024 Jan 4;22(1D):e237072. doi: 10.6004/jnccn.2023.7072. PMID 38176099