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评估晚期非小细胞肺癌患者在接受至少6个月系统治疗后病情得到控制时康复治疗益处的三项终点研究 (REHAB-CBNPC)

2026年10月12日 更新者：University Hospital, Grenoble

评估晚期非小细胞肺癌患者系统治疗至少6个月后病情稳定时康复获益的三项终点研究

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.

研究概览

地位

招聘中

条件

详细说明

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

研究类型

观察性的

注册 (估计的)

63

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hand-grip
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
体重（公斤）
大体时间：运动康复计划的围手术期
运动康复计划的围手术期
ONAPS-PAQ test
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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.
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Grenoble

调查人员

  • 首席研究员：Anne-Claire TOFFART、CHU Grenoble Alpes

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月15日

初级完成 (估计的)

2027年10月14日

研究完成 (估计的)

2027年10月14日

研究注册日期

首次提交

2025年12月22日

首先提交符合 QC 标准的

2026年2月19日

首次发布 (实际的)

2026年2月27日

研究记录更新

最后更新发布 (实际的)

2026年10月13日

上次提交的符合 QC 标准的更新

2026年10月12日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 38RC25.0268
  • 2025-A01837-42 (其他标识符：ID RCB)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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