Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07104630
Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
Led by Case Comprehensive Cancer Center · Updated on 2026-04-13
85
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating pulmonary rehabilitation as a supportive treatment for people who have been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many individuals with advanced NSCLC experience breathing difficulties and fatigue, which can reduce their quality of life. This study aims to understand whether pulmonary rehabilitation can improve functioning and reduce shortness of breath in these patients. It also explores challenges faced by patients and oncology care providers regarding pulmonary rehabilitation. The study has two parts. In the first part, participants are randomly assigned to one of two groups: one group receives an eight-week pulmonary rehabilitation program with two sessions per week led by certified respiratory therapists, including exercise, education on physical function, nutrition, and psychosocial health; the other group receives usual care, consisting of standard education on nutrition and physical activity for cancer survivors. The second part involves interviews with subsets of participants and medical care providers to identify barriers to pulmonary rehabilitation. Participants will attend study visits at the start and after eight weeks to measure changes in their functional capacity using a 6-minute walk test and report their breathing difficulties and quality of life through several validated scales. The study also tracks cancer-related adverse events reported by participants. Interviews will be conducted once between six and thirty months after enrollment to understand obstacles to pulmonary rehabilitation. The total participation duration varies with these assessments and follow-ups.
CONDITIONS
Brief Title
Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed non-small cell lung cancer, Stages III or IV treated with palliative intent
- Adults 18 years of age or older
- ECOG performance status of 3 or less
- No clinical or radiographic progression within the last three months
- Self-reported dyspnea with a score of 2 or higher on the modified Medical Research Council Dyspnea Scale
- Participants must be fluent in written and spoken English
You will not qualify if you...
- Participants being treated with curative intent for locally advanced or oligometastatic NSCLC with concurrent chemotherapy and radiation
- Evidence of clinical or radiographic progression
- Mental impairment preventing completion of study requirements
- High risk of fracture or spine instability (Mirels score 7 or higher, or SINS 7 or higher)
- Cardiac conditions including Class II, III, or IV heart failure, recent acute coronary syndromes or interventions within 6 months, uncontrolled arrhythmias (except stable atrial fibrillation), syncope, acute myocarditis, pericarditis, or endocarditis
- Acute pulmonary embolus or infarction within the last 3 months
- Acute thrombosis of lower extremities within the last 3 months
- Suspected dissecting aneurysm
- Pulmonary edema or respiratory failure
- Acute non-cardiopulmonary disorders affecting exercise performance or worsened by exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Pulmonary Rehabilitation
Duration - 8 weeks
Participants complete an 8-week course of pulmonary rehabilitation, attending sessions twice weekly. Each session includes review of physical function, nutrition, and psychosocial health, along with an individualized exercise prescription to follow throughout the course.
Two visits per week for 8 weeks
Follow-up Assessments
Duration - 1 day
Participants complete outcome assessments at the end of the 8-week pulmonary rehabilitation period to evaluate changes in functional capacity, dyspnea, quality of life, and adverse events.
1 visit (in-person) at 8 weeks
Qualitative Interviews
Duration - One-time between 6 and 30 months
Selected participants and medical care providers participate in one-time qualitative interviews between month 6 and 30 to assess attitudes and barriers to pulmonary rehabilitation.
1 interview visit
Trial Site Locations
Total: 1 location
1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
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Research Team
M
Melinda Hsu, MD, MS
P
Peronne Joseph
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Published Research Related To This Trial
Cancer statistics, 2023.
Rebecca L Siegel, Kimberly D Miller, Nikita Sandeep Wagle...
https://pubmed.ncbi.nlm.nih.gov/36633525Lung Cancer Incidence and Mortality with Extended Follow-up in the National Lung Screening Trial.
National Lung Screening Trial Research Team
https://pubmed.ncbi.nlm.nih.gov/31260833Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial.
Harry J de Koning, Carlijn M van der Aalst, Pim A de Jong...
https://pubmed.ncbi.nlm.nih.gov/31995683Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy.
U Pastorino, M Silva, S Sestini...
https://pubmed.ncbi.nlm.nih.gov/30937431Lung Cancer Survivorship: Physical, Social, Emotional, and Medical Needs of NSCLC Survivors.
Melinda L Hsu, Matthew Z Guo, Sarah Olson...
https://pubmed.ncbi.nlm.nih.gov/38176099Comparison of fatigue, depression, and anxiety as factors affecting posttreatment health-related quality of life in lung cancer survivors.
Ju Youn Jung, Jong Mog Lee, Moon Soo Kim...
https://pubmed.ncbi.nlm.nih.gov/28755492Unmet Needs, Quality of Life, and Financial Toxicity Among Survivors of Lung Cancer.
Melinda L Hsu, Mary C Boulanger, Sarah Olson...
https://pubmed.ncbi.nlm.nih.gov/38630475Pulmonary rehabilitation outcomes in individuals with chronic obstructive pulmonary disease: A systematic review.
Sara Souto-Miranda, Guilherme Rodrigues, Martijn A Spruit...
https://pubmed.ncbi.nlm.nih.gov/34329794Effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized controlled trials.
Hong Zhang, Dandan Hu, Yikai Xu...
https://pubmed.ncbi.nlm.nih.gov/35037535