Study of Three Endpoints to Assess the Benefit of Rehabilitation in Patients With Advanced Non-small Cell Lung Cancer Controlled After at Least 6 Months of Systemic Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment. Many people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life. Regular physical activity (PA) is recommended for the management of all chronic diseases, including cancer. PA can be done independently by the patient or supervised by adapted physical activity instructors (EAPA) at home or in a day hospital (HDJ) in medical and rehabilitation care departments (SMR), where it is covered by social security. Rehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer . In this study, patients will participate in a 3-month rehabilitation program. We will measure quality of life, hand grip strength, and the Five Times Sit to Stand Test, before and after the program. Other measures will include daily step counts, nutrition, overall health status, continuation of cancer treatment, program adherence, and participant satisfaction. About 63 participants will be recruited in several hospitals, including CHUGA, CHMS and CHANGE. This patients will be able to choose a program that suits them and is available as part of they care. We are expecting 50 patients to participate in one of the rehabilitation program. The main goal is to identify the most useful outcomes to assess in future studies that will compare different rehabilitation approaches for people with lung cancer.
Detailed description
This study (REHAB-CBNPC) is a prospective, multicenter, observational trial coordinated by Pr. Anne-Claire Toffart and sponsored by CHU Grenoble Alpes. It aims to identify the most relevant outcome measure to evaluate the benefit of rehabilitation programs in patients with advanced or metastatic non-small cell lung cancer whose disease remains controlled after at least 6 months of systemic treatment.
Regular physical activity is recommended for people with chronic diseases, including cancer. In non-small cell lung cancer, preoperative and postoperative rehabilitation has demonstrated benefits, particularly in patients with impaired respiratory function. However, evidence regarding rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease is controlled at distance from initial treatment remains scarce. These patients frequently experience cancer-related fatigue, reduced activity levels, and impaired quality of life, highlighting the need for adapted rehabilitation approaches.
Eligible participants will be adults with locally advanced or metastatic non-small cell lung cancer, ECOG-PS 0-2, and a self-reported functional limitation, recruited from three centers in the Auvergne-Rhône-Alpes region of France (CHU Grenoble Alpes, CH Chambéry, CH Annecy-Genevois). Rehabilitation programs will be delivered according to local practice, either in specialized rehabilitation units (SMR), hospital-based day programs, or at home with adapted physical activity providers.
Approximately 63 patients will be enrolled to participate in a study on physical activity, they will be recruited at one of the participating centers during consultations with their referring oncologist. anticipating that about 50 will complete a rehabilitation program. If they meet all the inclusion criteria and do not have any exclusion criteria, they will be offered the opportunity to participate in a study on physical activity. They will then have the choice of whether or not to participate.
If they agree, they will be able to choose a rehabilitation program that suits them and is available as part of their care.
Each participant will be followed for 3 months, and data will be collected through electronic case report forms (REDCap).
This exploratory study will evaluate three main outcomes before and after a 3-month rehabilitation program: quality of life (EQ-5D-5L), hand grip strength, and the five-times sit-to-stand test. The study will also assess feasibility and sensitivity to change of additional measures, including step counts, physical activity and sedentary behavior (ONAPS-PAQ), nutritional status, performance status (ECOG-PS), continuation of systemic treatment, adherence to the program, causes of non-participation, and patient satisfaction (CSQ-8).
Quantitative variables will be described by their means and standard deviations, as well as medians and interquartile ranges. Qualitative variables will be described by the associated numbers and percentages. Any normality will be verified graphically.
The expected outcomes include a better understanding of feasibility, adherence, and sensitivity of candidate endpoints. Results will inform the selection of the most appropriate primary endpoint for future randomized controlled trials comparing rehabilitation strategies in advanced non-small cell lung cancer
Primary outcome measures
- Hand-grip [Time frame: periprocedural of the exercise rehabilitation program]
- EQ5DL Score [Time frame: periprocedural of the exercise rehabilitation program]
- Five Times Sit To Stand [Time frame: periprocedural of the exercise rehabilitation program]
Secondary outcome measures (9)
- ONAPS-PAQ test [Time frame: periprocedural of the exercise rehabilitation program]
- ECOG-PS [Time frame: periprocedural of the exercise rehabilitation program]
- CSQ-8 [Time frame: through study completion, an average of 3 months]
- Average number of steps in the previous week (using smartphone app) [Time frame: periprocedural of the exercise rehabilitation program]
- Continuation of oncological treatment [Time frame: through study completion, an average of 3 months]
- Weight (in kg) [Time frame: periprocedural of the exercise rehabilitation program]
- Reason for refusing/not participating in a program [Time frame: At Baseline]
- Adherence to the rehabilitation program. [Time frame: through study completion, an average of 3 months]
- Adverse events [Time frame: through study completion, an average of 3 months]
Eligibility criteria
Inclusion criteria
- Adult patients treated for NSCLC at CHUGA, CHMS, or CHANGE
- Locally advanced or metastatic NSCLC
- Tumor disease controlled for at least 6 months following any type of anti-tumor treatment
- ECOG Performance Status 0 to 2
- Patient reporting functional complaints related to physical activity
- Covered by the national health insurance system
Exclusion criteria
- Initial management of the tumor disease started ≥ 2 years ago
- Residual toxicity of grade ≥ 2
- Estimated life expectancy less than 6 months (at the discretion of the investigator)
- Patient with an absolute contraindication to physical activity at the time of consultation (e.g., unstable angina; acute intercurrent event...)
- Subject currently in an exclusion period from another study or participating in an interventional study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 3 centers
- CH Métropole Savoie — Chambéry
- Centre Hospitalier Annecy Genevois — Annecy
- CHU Grenoble Alpes — Grenoble
Publications
- Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819. PMID 35393316
- Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907. PMID 33568371
Identifiers
NCT: NCT07434947 · 38RC25.0268 · 2025-A01837-42