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

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

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