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

NCT07434947 | Not Yet Recruiting

• 2 other identifiers: 38RC25.02682025-A01837-42
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

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

Lung Cancer (NSCLC)

Keywords

readaptation; Physical activity

Outcome Measures

Primary Outcomes (3)

• Hand-grip

  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

  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

  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 Outcomes (9)

• ONAPS-PAQ test

  periprocedural of the exercise rehabilitation program

• ECOG-PS

  periprocedural of the exercise rehabilitation program

• CSQ-8

  through study completion, an average of 3 months

• Average number of steps in the previous week (using smartphone app)

  periprocedural of the exercise rehabilitation program

• Continuation of oncological treatment

  through study completion, an average of 3 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (3)

CH Métropole Savoie

Chambéry, Chambéry, 73 100, France

Location

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Behavior

Study Officials

• Anne-Claire TOFFART

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Claire TOFFART

CONTACT

33 +(0)4 76 76 68 31; AToffart@chu-grenoble.fr

Etienne FOULON

CONTACT

EFoulon1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (3)