ClinicalTrials.gg
RecruitingNCT07104630Updated Sep 22, 2026

Pulmonary Rehabilitation in Advanced Lung Cancer Survivors

A Phase 2 interventional study of Pulmonary Rehabilitation (PR) and No intervention: Usual care in Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage IV and Non-small Cell Lung Cancer, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Carcinoma, Non-Small-Cell Lung by Case Comprehensive Cancer Center — 1 open to participants now, 1 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Case Comprehensive Cancer Center.

Planned enrollment
Largest of 18
85 · median 13
Started
2026
the only one that year
Phase 2
9 of 24
1 open now
Registered
24th of 24
by date

Among the 24 studies in Carcinoma, Non-Small-Cell Lung by Case Comprehensive Cancer Center, this one has the largest planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2026, is one of 9 in phase 2, and was the 24th registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

1 of the 24 studies in Carcinoma, Non-Small-Cell Lung by Case Comprehensive Cancer Center is open now, in 1 country.

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Carcinoma, Non-Small-Cell Lung by Case Comprehensive Cancer Center, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • Pulmonary Rehabilitation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have confirmed NSCLC, Stages III or IV treated with palliative intent
  • Adults ≥ 18 years of age
  • 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

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 (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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Experimental
    Pulmonary Rehabilitation (PR)

    Behavioral: Pulmonary Rehabilitation (PR)

  • Active comparator
    Usual care

    Other: No intervention: 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

  • BehavioralPulmonary 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.

  • OtherNo 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.

06

What researchers measure

Primary outcomes

  1. Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)

    The 6MWT measures the distance (in meters) that a person can walk in 6 minutes, with higher values indicating greater functional capacity

    Time frame: Baseline, 8 weeks

  2. Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS)

    The 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.

    Time frame: Baseline, 8 weeks

  3. Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30

    The 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.

    Time frame: Baseline, 8 weeks

  4. Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29

    The 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.

    Time frame: Baseline, 8 weeks

  5. 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

Secondary outcomes

  1. Participants' barriers to pulmonary rehabilitation in LCS with advanced NSCLC, as measured by thematic findings from qualitative interviews

    Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.

    Time frame: One-time interview between month 6 and 30

  2. Thoracic oncology providers' barriers to referral to pulmonary rehabilitation, as measured by thematic findings from qualitative interviews

    Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.

    Time frame: One-time interview between month 6 and 30

07

Study locations

1 of 1 sites recruiting
  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106, United States
    Recruiting
    • Melinda Hsu, MD, MS · Contact
    • Melinda Hsu, MD, MS · Principal investigator
08

References and documents

Publications

  • Sung 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. PubMed 33538338 ↗
  • Siegel 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. PubMed 36633525 ↗
  • National 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. PubMed 31260833 ↗
  • de 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. PubMed 31995683 ↗
  • Pastorino 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. PubMed 30937431 ↗
  • Hsu 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. PubMed 38176099 ↗
  • Jung JY, Lee JM, Kim MS, Shim YM, Zo JI, Yun YH. Comparison of fatigue, depression, and anxiety as factors affecting posttreatment health-related quality of life in lung cancer survivors. Psychooncology. 2018 Feb;27(2):465-470. doi: 10.1002/pon.4513. Epub 2017 Aug 17. PubMed 28755492 ↗
  • Hsu ML, Boulanger MC, Olson S, Eaton C, Prichett L, Guo M, Miller M, Brahmer J, Forde PM, Marrone KA, Turner M, Feliciano JL. Unmet Needs, Quality of Life, and Financial Toxicity Among Survivors of Lung Cancer. JAMA Netw Open. 2024 Apr 1;7(4):e246872. doi: 10.1001/jamanetworkopen.2024.6872. PubMed 38630475 ↗
  • Souto-Miranda S, Rodrigues G, Spruit MA, Marques A. Pulmonary rehabilitation outcomes in individuals with chronic obstructive pulmonary disease: A systematic review. Ann Phys Rehabil Med. 2022 May;65(3):101564. doi: 10.1016/j.rehab.2021.101564. Epub 2021 Nov 15. PubMed 34329794 ↗
  • Zhang H, Hu D, Xu Y, Wu L, Lou L. Effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized controlled trials. Ann Med. 2022 Dec;54(1):262-273. doi: 10.1080/07853890.2021.1999494. PubMed 35037535 ↗
  • Troosters T, Casaburi R, Gosselink R, Decramer M. Pulmonary rehabilitation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38. doi: 10.1164/rccm.200408-1109SO. Epub 2005 Mar 18. No abstract available. PubMed 15778487 ↗
  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. PubMed 24127811 ↗
  • Rochester CL, Alison JA, Carlin B, Jenkins AR, Cox NS, Bauldoff G, Bhatt SP, Bourbeau J, Burtin C, Camp PG, Cascino TM, Dorney Koppel GA, Garvey C, Goldstein R, Harris D, Houchen-Wolloff L, Limberg T, Lindenauer PK, Moy ML, Ryerson CJ, Singh SJ, Steiner M, Tappan RS, Yohannes AM, Holland AE. Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2023 Aug 15;208(4):e7-e26. doi: 10.1164/rccm.202306-1066ST. PubMed 37581410 ↗
  • Ng AH, Ngo-Huang A, Vidal M, Reyes-Garcia A, Liu DD, Williams JL, Fu JB, Yadav R, Bruera E. Exercise Barriers and Adherence to Recommendations in Patients With Cancer. JCO Oncol Pract. 2021 Jul;17(7):e972-e981. doi: 10.1200/OP.20.00625. Epub 2021 Mar 19. PubMed 33739853 ↗
  • Granger CL, Denehy L, Remedios L, Retica S, Phongpagdi P, Hart N, Parry SM. Barriers to Translation of Physical Activity into the Lung Cancer Model of Care. A Qualitative Study of Clinicians' Perspectives. Ann Am Thorac Soc. 2016 Dec;13(12):2215-2222. doi: 10.1513/AnnalsATS.201607-540OC. PubMed 27689958 ↗

Individual participant data

Plan to share: Yes — Data included in the peer reviewed publication will be publicly available. No raw data will be shared.

Time frame: At time of publication of primary endpoints or 2 years post-trial completion, whichever is sooner.

Access criteria: Peer reviewed publication will be publicly available.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 9 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2025
First posted
Aug 5, 2025
StartActual
Mar 16, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07104630
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Aug 5, 2025
Start date
Mar 16, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Melinda Hsu, MD, MS
Contact
Melinda.hsu@uhhospitals.org
216-286-6505
Peronne Joseph
Contact
Peronne.Joseph@uhhospitals.org
216-844-8573
Melinda Hsu, MD, MS
principal investigator · Case Comprehensive Cancer Center, University Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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