이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

전신 치료 6개월 이상 후 조절된 진행성 비소세포폐암 환자에서 재활의 이점을 평가하기 위한 3가지 종료점 연구 (REHAB-CBNPC)

2026년 10월 12일 업데이트: University Hospital, Grenoble

최소 6개월의 전신 치료 후 조절된 진행성 비소세포폐암 환자의 재활 효과를 평가하기 위한 세 가지 종점에 관한 연구

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.

연구 개요

상태

모병

정황

폐암(NSCLC)

상세 설명

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

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Anne-Claire TOFFART
전화번호: 33 +(0)4 76 76 68 31
이메일: AToffart@chu-grenoble.fr

연구 연락처 백업

이름: Etienne FOULON
이메일: EFoulon1@chu-grenoble.fr

연구 장소

프랑스
- - Annecy, 프랑스, 74370
    - 아직 모집하지 않음
    - Centre Hospitalier Annecy Genevois
    - 연락하다:
      
      Océane VENDRASCO
      
      이메일: ovendrasco@ch-annecygenevois.fr
    - 수석 연구원:
      
      Valerie PAULUS
    - 연락하다:
      
      Valerie PAULUS
      
      이메일: vpaulus@ch-annecygenevois.fr
  - Chambéry, 프랑스, 73 100
    - 모병
    - CH Métropole Savoie
    - 연락하다:
      
      Julian PINSOLLE
      
      이메일: julian.pinsolle@ch-metropole-savoie.fr
    - 수석 연구원:
      
      Julian PINSOLLE
  - Grenoble, 프랑스, 38043
    - 아직 모집하지 않음
    - CHU Grenoble Alpes
    - 수석 연구원:
      
      Anne-Claire TOFFART
    - 연락하다:
      
      Anne-Claire TOFFART
      
      전화번호: 33 +(0)4 76 76 68 31
      
      이메일: AToffart@chu-grenoble.fr
    - 연락하다:
      
      Etienne FOULON
      
      이메일: EFoulon1@chu-grenoble.fr

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Hand-grip 기간: 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 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
몸무게 (kg 단위) 기간: 운동 재활 프로그램의 주변 시술		운동 재활 프로그램의 주변 시술
ONAPS-PAQ test 기간: 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 기간: 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 기간: 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) 기간: 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 기간: 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 기간: 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. 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Grenoble

수사관

수석 연구원: Anne-Claire TOFFART, CHU Grenoble Alpes

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 15일

기본 완료 (추정된)

2027년 10월 14일

연구 완료 (추정된)

2027년 10월 14일

연구 등록 날짜

최초 제출

2025년 12월 22일

QC 기준을 충족하는 최초 제출

2026년 2월 19일

처음 게시됨 (실제)

2026년 2월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 12일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

38RC25.0268
2025-A01837-42 (기타 식별자: ID RCB)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .