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Tanulmány három végpontról a rehabilitáció előnyeinek felmérésére előrehaladott nem kissejtes tüdőrákban szenvedő betegeknél, akiknél a rendszerszintű kezelés után legalább 6 hónapos kontroll állt fenn (REHAB-CBNPC)

2026. október 12. frissítette: University Hospital, Grenoble

Tanulmány három végpontról a rehabilitáció hasznának értékelésére előrehaladott nem-kissejtes tüdőrákban szenvedő betegeknél, akiknek betegsége legalább 6 hónapos szisztémás kezelés után kontrollált

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Részletes leírás

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

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

63

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: COHORT
  • Időperspektívák: PROSPECTIVE

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Hand-grip
Időkeret: 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
Időkeret: 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
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Súly (kg-ban)
Időkeret: a gyakorlati rehabilitációs program periprocedurális vonatkozása
a gyakorlati rehabilitációs program periprocedurális vonatkozása
ONAPS-PAQ test
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Reason for refusing/not participating in a program
Időkeret: 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.
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University Hospital, Grenoble

Nyomozók

  • Kutatásvezető: Anne-Claire TOFFART, CHU Grenoble Alpes

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. április 15.

Elsődleges befejezés (Becsült)

2027. október 14.

A tanulmány befejezése (Becsült)

2027. október 14.

Tanulmányi regisztráció dátumai

Először benyújtva

2025. december 22.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. február 19.

Első közzététel (Tényleges)

2026. február 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. október 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. október 12.

Utolsó ellenőrzés

2026. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 38RC25.0268
  • 2025-A01837-42 (Egyéb azonosító: ID RCB)

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Nem

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