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
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
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.
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:
Exclusion Criteria:
AToffart@chu-grenoble.fr33 +(0)4 76 76 68 31
EFoulon1@chu-grenoble.fr
vpaulus@ch-annecygenevois.fr
ovendrasco@ch-annecygenevois.fr
AToffart@chu-grenoble.fr33 +(0)4 76 76 68 31
EFoulon1@chu-grenoble.fr