Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
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 (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with metastatic or locally advanced non-small cell lung cancer.
- description
- The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumour disease is controlled and who are at least 6 months into any anti-tumour treatment. They must have a functional complaint concerning physical activity.
Primary outcomes (3)
- measure
- Hand-grip
- timeFrame
- periprocedural of the exercise rehabilitation program
- description
- Hand grip strength is measured with a hand dynamometer. It is a measure of grip strength in kilograms, which is associated with muscle mass. The subject holds the device in one hand, usually with the elbow at 90° and the wrist straight. On signal, they squeeze as hard as possible for a few seconds. The test is repeated 2-3 times for each hand, and the best or average value is recorded.
- measure
- EQ5DL Score
- timeFrame
- periprocedural of the exercise rehabilitation program
- description
- EQ5DL is a score about life quality. It includes two part: The first part assesses health in five dimensions, each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part consists of a visual analogue scale (VAS) on which rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGouez 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
- BACKGROUNDCatho 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