Studie av tre slutpunkter för att bedöma nyttan av rehabilitering hos patienter med avancerad icke-småcellig lungcancer kontrollerad efter minst 6 månaders systemisk behandling (REHAB-CBNPC)
Studie av tre slutpunkter för att utvärdera nyttan av rehabilitering hos patienter med avancerad icke-småcellig lungcancer kontrollerad efter minst 6 månaders systemisk behandling
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Anne-Claire TOFFART
- Telefonnummer: 33 +(0)4 76 76 68 31
- E-post: AToffart@chu-grenoble.fr
Studera Kontakt Backup
- Namn: Etienne FOULON
- E-post: EFoulon1@chu-grenoble.fr
Studieorter
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-
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Annecy, Frankrike, 74370
- Har inte rekryterat ännu
- Centre Hospitalier Annecy Genevois
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Kontakt:
- Océane VENDRASCO
- E-post: ovendrasco@ch-annecygenevois.fr
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Huvudutredare:
- Valerie PAULUS
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Kontakt:
- Valerie PAULUS
- E-post: vpaulus@ch-annecygenevois.fr
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Chambéry, Frankrike, 73 100
- Rekrytering
- CH Métropole Savoie
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Kontakt:
- Julian PINSOLLE
- E-post: julian.pinsolle@ch-metropole-savoie.fr
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Huvudutredare:
- Julian PINSOLLE
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Grenoble, Frankrike, 38043
- Har inte rekryterat ännu
- CHU Grenoble Alpes
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Huvudutredare:
- Anne-Claire TOFFART
-
Kontakt:
- Anne-Claire TOFFART
- Telefonnummer: 33 +(0)4 76 76 68 31
- E-post: AToffart@chu-grenoble.fr
-
Kontakt:
- Etienne FOULON
- E-post: EFoulon1@chu-grenoble.fr
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hand-grip
Tidsram: 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
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|
EQ5DL Score
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Vikt (i kg)
Tidsram: periprocedural av träningsrehabiliteringsprogrammet
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periprocedural av träningsrehabiliteringsprogrammet
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ONAPS-PAQ test
Tidsram: periprocedural of the exercise rehabilitation program
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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
Tidsram: 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
|
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CSQ-8
Tidsram: through study completion, an average of 3 months
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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)
Tidsram: 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
Tidsram: through study completion, an average of 3 months
|
We will collect information on the patient's cancer treatment:
|
through study completion, an average of 3 months
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Reason for refusing/not participating in a program
Tidsram: 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
|
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Adherence to the rehabilitation program.
Tidsram: through study completion, an average of 3 months
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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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Anne-Claire TOFFART, CHU Grenoble Alpes
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 38RC25.0268
- 2025-A01837-42 (Annan identifierare: ID RCB)
Läkemedels- och apparatinformation, studiedokument
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