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 (REHAB-CBNPC)

February 19, 2026 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Not yet recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumor disease is controlled and who are at least 6 months post-treatment with any anti-tumor therapy.

They must have a complaint related to physical activity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with metastatic or locally advanced non-small cell lung cancer.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand-grip
Time Frame: periprocedural of the exercise rehabilitation program

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.
periprocedural of the exercise rehabilitation program
EQ5DL Score
Time Frame: periprocedural of the exercise rehabilitation program

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).
periprocedural of the exercise rehabilitation program
Five Times Sit To Stand
Time Frame: periprocedural of the exercise rehabilitation program
The subject sits on a chair , with arms crossed over the chest. On the tester's signal, the subject stands up fully and sits back down five times as quickly as possible without using the arms for support. The time needed to complete the five repetitions is measured.
periprocedural of the exercise rehabilitation program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ONAPS-PAQ test
Time Frame: periprocedural of the exercise rehabilitation program

The Onaps-PAQ questionnaire assesses the level of physical activity and sedentary behavior during a typical week for the adult population. It is divided into three parts and 21 questions: activities at work, trips for practical purposes, and leisure or home activities. This questionnaire also assesses sedentary behavior in all areas of life (travel, work, leisure).

Patients are considered to be very active, active, or inactive. There are also three levels of sedentary behavior: low, moderate, and high.
periprocedural of the exercise rehabilitation program
ECOG-PS
Time Frame: periprocedural of the exercise rehabilitation program
It describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status Scale measure how the disease impacts a patient's daily living abilities, known to physicians and researchers as a patient's performance status.
periprocedural of the exercise rehabilitation program
CSQ-8
Time Frame: through study completion, an average of 3 months
It is the Client Satisfaction Questionnaire. It will be use to measure and assess consumer satisfaction with health and human services. There are 8 questions, total scores range from 8 to 32, with the higher number indicating greater satisfaction.
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
If it's available, on a app, it is the number of steps the week before.
periprocedural of the exercise rehabilitation program
Continuation of oncological treatment
Time Frame: through study completion, an average of 3 months

We will collect information on the patient's cancer treatment:

  • Same as before rehabilitation
  • Treatment modified due to tumor progression
  • Treatment discontinued because no longer indicated (no tumor progression)
  • Treatment discontinued because of palliative care only
through study completion, an average of 3 months
Weight (in kg)
Time Frame: periprocedural of the exercise rehabilitation program
periprocedural of the exercise rehabilitation program
Reason for refusing/not participating in a program
Time Frame: At Baseline
If patients agree to participate in the study but do not wish to participate in any rehabilitation program, we will collect the reason for this.
At Baseline
Adherence to the rehabilitation program.
Time Frame: through study completion, an average of 3 months
We will collect data if the patient has completed the entire program until the end (with the possibility of a few sessions not being completed).
through study completion, an average of 3 months
Adverse events
Time Frame: through study completion, an average of 3 months
We will collect adverse events related to the tumor disease (including treatment and cancer itself) or the rehabilitation program, as well as the consequences.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Anne-Claire TOFFART, CHU Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC25.0268
  • 2025-A01837-42 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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