[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626385":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":52,"studyPopulation":53,"armGroups":54,"interventions":38,"overallOfficials":58,"centralContacts":63,"locations":71,"responsibleParty":120,"collaborators":38,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":38,"enrollmentInfo":131,"targetDuration":38,"studyType":134,"phases":38,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":95,"whyStopped":38,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":38},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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.\n\nThe 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",{"measure":14,"description":15,"timeFrame":12},"EQ5DL Score","EQ5DL is a score about life quality. It includes two part:\n\nThe 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\u002Funable 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.\n\nThe second part consists of a visual analogue scale (VAS) on which rates his\u002Fher perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).",{"measure":17,"description":18,"timeFrame":12},"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.",[20,23,26,30,33,36,39,43,46],{"measure":21,"description":22,"timeFrame":12},"ONAPS-PAQ test","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).\n\nPatients are considered to be very active, active, or inactive. There are also three levels of sedentary behavior: low, moderate, and high.",{"measure":24,"description":25,"timeFrame":12},"ECOG-PS","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.",{"measure":27,"description":28,"timeFrame":29},"CSQ-8","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",{"measure":31,"description":32,"timeFrame":12},"Average number of steps in the previous week (using smartphone app)","If it's available, on a app, it is the number of steps the week before.",{"measure":34,"description":35,"timeFrame":29},"Continuation of oncological treatment","We will collect information on the patient's cancer treatment:\n\n* Same as before rehabilitation\n* Treatment modified due to tumor progression\n* Treatment discontinued because no longer indicated (no tumor progression)\n* Treatment discontinued because of palliative care only",{"measure":37,"description":38,"timeFrame":12},"Weight (in kg)",null,{"measure":40,"description":41,"timeFrame":42},"Reason for refusing\u002Fnot participating in a program","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",{"measure":44,"description":45,"timeFrame":29},"Adherence to the rehabilitation program.","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).",{"measure":47,"description":48,"timeFrame":29},"Adverse events","We will collect adverse events related to the tumor disease (including treatment and cancer itself) or the rehabilitation program, as well as the consequences.",{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":50,"timePerspective":51,"maskingInfo":38},"COHORT","PROSPECTIVE","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.\n\nRegular 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.\n\nEligible 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.\n\nApproximately 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.\n\nIf they agree, they will be able to choose a rehabilitation program that suits them and is available as part of their care.\n\nEach participant will be followed for 3 months, and data will be collected through electronic case report forms (REDCap).\n\nThis 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).\n\nQuantitative 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.\n\nThe 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","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.\n\nThey must have a complaint related to physical activity.",[55],{"label":56,"type":38,"description":57,"interventionNames":38},"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.",[59],{"name":60,"affiliation":61,"role":62},"Anne-Claire TOFFART","CHU Grenoble Alpes","PRINCIPAL_INVESTIGATOR",[64,68],{"name":60,"role":65,"phone":66,"phoneExt":38,"email":67},"CONTACT","33 +(0)4 76 76 68 31","AToffart@chu-grenoble.fr",{"name":69,"role":65,"phone":38,"phoneExt":38,"email":70},"Etienne FOULON","EFoulon1@chu-grenoble.fr",[72,93,108],{"facility":73,"status":74,"city":75,"state":38,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Centre Hospitalier Annecy Genevois","NOT_YET_RECRUITING","Annecy","74370","France","FR",{"type":80,"coordinates":81},"Point",[82,83],6.12565,45.90878,{"lat":83,"lon":82},[86,89,92],{"name":87,"role":65,"phone":38,"phoneExt":38,"email":88},"Valerie PAULUS","vpaulus@ch-annecygenevois.fr",{"name":90,"role":65,"phone":38,"phoneExt":38,"email":91},"Océane VENDRASCO","ovendrasco@ch-annecygenevois.fr",{"name":87,"role":62,"phone":38,"phoneExt":38,"email":38},{"facility":94,"status":95,"city":96,"state":38,"zip":97,"country":77,"countryCode":78,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"CH Métropole Savoie","RECRUITING","Chambéry","73 100",{"type":80,"coordinates":99},[100,101],5.92079,45.56628,{"lat":101,"lon":100},[104,107],{"name":105,"role":65,"phone":38,"phoneExt":38,"email":106},"Julian PINSOLLE","julian.pinsolle@ch-metropole-savoie.fr",{"name":105,"role":62,"phone":38,"phoneExt":38,"email":38},{"facility":61,"status":74,"city":109,"state":38,"zip":110,"country":77,"countryCode":78,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Grenoble","38043",{"type":80,"coordinates":112},[113,114],5.71479,45.17869,{"lat":114,"lon":113},[117,118,119],{"name":60,"role":65,"phone":66,"phoneExt":38,"email":67},{"name":69,"role":65,"phone":38,"phoneExt":38,"email":70},{"name":60,"role":62,"phone":38,"phoneExt":38,"email":38},{"type":121,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100626385","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-100626385",false,"NCT07434947","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","REHAB-CBNPC","Inclusion Criteria:\n\n* Adult patients treated for NSCLC at CHUGA, CHMS, or CHANGE\n* Locally advanced or metastatic NSCLC\n* Tumor disease controlled for at least 6 months following any type of anti-tumor treatment\n* ECOG Performance Status 0 to 2\n* Patient reporting functional complaints related to physical activity\n* Covered by the national health insurance system\n\nExclusion Criteria:\n\n* Initial management of the tumor disease started ≥ 2 years ago\n* Residual toxicity of grade ≥ 2\n* Estimated life expectancy less than 6 months (at the discretion of the investigator)\n* Patient with an absolute contraindication to physical activity at the time of consultation (e.g., unstable angina; acute intercurrent event...)\n* Subject currently in an exclusion period from another study or participating in an interventional study","ALL","18 Years",{"count":132,"type":133},63,"ESTIMATED","OBSERVATIONAL","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.\n\nMany people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life.\n\nRegular 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.\n\nRehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer .\n\nIn 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.\n\nAbout 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.\n\nThe 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.",[137],"Lung Cancer (NSCLC)",[139,140],"readaptation","Physical activity","2026-10-12",{"date":143,"type":144},"2026-10-13","ACTUAL",{"date":146,"type":144},"2026-04-15",{"date":148,"type":133},"2027-10-14",{"name":5,"class":6},3]