Nctid:
NCT06230016
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000267", "term"=>"Tissue Adhesions"}], "ancestors"=>[{"id"=>"D000002921", "term"=>"Cicatrix"}, {"id"=>"D000005355", "term"=>"Fibrosis"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M3620", "name"=>"Tissue Adhesions", "asFound"=>"Adhesion", "relevance"=>"HIGH"}, {"id"=>"M6160", "name"=>"Cicatrix", "relevance"=>"LOW"}, {"id"=>"M8485", "name"=>"Fibrosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2026-01-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2023-12-26", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-16", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Adhesion to an APA programm", "timeFrame"=>"4 to 6 months", "description"=>"Adherence of children and adolescents undergoing cancer treatment to personalized support in Adapted Physical Activity \\[APA\\] offered at an early stage and for a minimum duration of 4 to 6 months : patients following the whole APA program/patients included, in percent"}], "secondaryOutcomes"=>[{"measure"=>"Motivation and restraints", "timeFrame"=>"4 to 6 months", "description"=>"This outcome is measured through a semi directive questionnaire elaborated by the SENS laboratory (Laboratory of physical exercice and social environment, Grenoble, France). It measures attitudes and motivations that have been identified as key factors in behavior change, within the framework of the main health psychology models of behavior change, such as the theory of planned behavior, the health action process approach, or self-determination theory .In order to measure these constructs, tools adapted to children from 8 years old and scientifically validated were identified in the scientific literature and adapted for the APADHOP project.\n\nChildren with cancer over 8 years old and one or both parents will answer to questions at the start of the adapted physical activity programm ((APA) and after 4 to 6 months of APA personnalised support.\n\nThere is no scoring as this is a descriptive outcome (after been analyzed by a humanities and social sciences researcher)"}, {"measure"=>"Quality of life measure", "timeFrame"=>"4 to 6 months", "description"=>"Quality of life will be measured by international validated PedsQL questionnaires V4.0 (paediatric quality of Life Inventory) according to the age of the patient:\n\n* For parents of children aged 2-4 years:\n* For parents of children aged 5 to 7\n* For parents of children aged 8 to 12\n* For parents of children aged 13 to 18\n* For children aged 5 to 7\n* For children aged 8 to 12\n* For children aged 13 to 18 This questionnaires will be administrated at the start of the adapted physical activity (APA) programm and after 4 to 6 months of personalized APA support.\n\nEach item of the questionnaire is scored between 0 and 4 and the total score of the questionnaire is between 0 an 100. The higher score means a better quality of life.\n\nTo be able to measure the score at least 50% of the items must be answered. The results will be analysed only for patients and parents who have answered to the questionnaires at both evaluation time."}, {"measure"=>"Representation of physical activity", "timeFrame"=>"4 to 6 months", "description"=>"The evaluation of the representation of physical activity Activity of children and parents at diagnosis and after 4 to 6 months of personalized APA support will be performed through a semi directive questionnaire elaborated by the SENS Laboratory (Laboratory of physical exercice and social environment, Grenoble University in France).\n\nThe questionnaires will be administred to patients over 8 years and parents at the start of the adapted physical activity (APA) programm and after 4 to 6 months of personalized APA support. The effect of personalized support will also be studied by carrying out pre/post analyzes of these dimensions.\n\nThere is no scoring as this is a descriptive outcome that will be analysed by humanities and social siences university researchers."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["motivation", "restraint"], "conditions"=>["Childhood Cancer", "Adapted Physical Activity"]}, "descriptionModule"=>{"briefSummary"=>"Adapted physical activity session with a formed professional is proposed in standard care since 2022 in the immuno-hematological service to all children with newly diagnosed cancer or relapse.\n\nThe aim of this study is to keep the children in the APA programm during all the treatment lenght.\n\nThis study aims to evaluate by questionnaires the motivation keys and restraint from children and parents before the APA program starts (at diagnosis or relapse if not previously participating to an APA programm) and after 4 to 6 months of APA programm.\n\nThe final expected fallout is to enhance children adhesion to long term APA program by implementing tools in current practice to overcome restraints from young patients and their parents", "detailedDescription"=>"The literature and the French Cancer Plan confirm the benefits of physical activity for cancer patients, and underline the importance of developing appropriate physical activity support for children and adolescents, given their specific needs and the societal and public health challenge represented by these budding patients.\n\nDespite the abundance of studies relating to physical activity in oncology, few data are available, particularly in the pediatric and adolescent/young adult population :\n\n* on physical activity interventions initiated early and sustained over time\n* on personalized physical activity interventions integrated into the patient's care/life trajectory\n* on factors favoring adhesion to an adapted physical activity program \\[APA\\] during and/or after cancer treatment\n\nThis is a prospective, exploratory, monocentric study to explore these points.\n\nAs part of routine management in the immunohaemato-oncology \\[IHO\\] department of the Grenoble Alpes University Hospital, a personalized physical activity \\[PA\\] program is systematically proposed by a PA professional, with a program adapted to the child, his or her motivations and limitations.\n\nAs part of the protocol, a questionnaire-based assessment of motivations and obstacles, as well as quality of life, will be carried out at the start of the PA program and again after 4 to 6 months. Criteria for adherence to the APA program will also be collected.\n\nEXPECTED OUTPUTS\n\n* Propose an organizational model in pediatric oncology for the early and sustained practice of APA with children and adolescents hospitalized for cancer.\n* Finalize assessment and follow-up materials for children receiving APA support in pediatric oncology (information leaflets, certificate of no contra-indication to APA, assessment and follow-up form, questionnaire on attitude and motivation to APA, etc.).\n* Provide guidance to help young cancer patients adhere more effectively to APA program.\n* Participate in the promotion of APA and the development of APA recommendations for children and adolescents treated for cancer, in conjunction with the SFCE (Children Cancer French Society) national working group on APA for children and adolescents with cancer."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"3 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Children with cancer taken in charge in the paediatric immuno haematology service of the Grenoble Alpes University Hospital", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients aged 3 years to under 18 years under care at Grenoble Alpes University Hospital\n* New cancer diagnosis or relapse in the absence of previous APA treatment\n* All cancer pathologies:\n\nDiagnosis of acute or chronic hematological malignancy OR Central nervous system tumors OR Other solid tumors\n\n* Regardless of therapeutic pathway\n* Parents and patient over 5 years old understanding french langage\n* Patient and parents who have not objected to participation after being informed\n\nExclusion Criteria:\n\n* Patient with a strict medical contraindication to physical activity identified by the referring physician or another specialist physician, particularly the sports physician (unstabilized heart or lung disease, uncontrolled diabetes, etc.)"}, "identificationModule"=>{"nctId"=>"NCT06230016", "acronym"=>"APADHOP", "briefTitle"=>"Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity Program", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Grenoble"}, "officialTitle"=>"Evaluation of the Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity", "orgStudyIdInfo"=>{"id"=>"2023-A02343-42"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"questionnaires", "type"=>"OTHER", "description"=>"human and social science questionnaire (specifically designed by the expert lab of Grenoble) on motivation and restraint perceived by patient and parents, elaborated especially for this study.\n\nQuestionnaire administred before the start of current care APA programm and after 4 to 6 months."}, {"name"=>"PedsQL quality of life questionnaires", "type"=>"OTHER", "description"=>"validated PedsQL (The Pediatric Quality of Life Inventory) questionnaires administred to children (if adequate) and parents before the start of current care APA programm and after 4 to 6 months"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"38000", "city"=>"Grenoble", "state"=>"Isere", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Isabelle Schiff", "role"=>"CONTACT", "email"=>"ISchiff@chu-grenoble.fr", "phone"=>"+33476766561"}, {"name"=>"Leila Gofti Laroche", "role"=>"CONTACT", "email"=>"LGofti-laroche@chu-grenoble.fr", "phone"=>"+33625574699"}, {"name"=>"Mélanie balleeger", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"anne pagnier", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"cécile perret", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"gaelle stofleth", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"corinne armari alla", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"severine bobillier chaumont", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"dalila adjaoud", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Leila Gofti Laroche", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"CHU Grenoble Alpes", "geoPoint"=>{"lat"=>45.16667, "lon"=>5.71667}}], "centralContacts"=>[{"name"=>"Isabelle Schiff, PHD", "role"=>"CONTACT", "email"=>"ISchiff@chu-grenoble.fr", "phone"=>"+33476766561"}, {"name"=>"Laura Chambon", "role"=>"CONTACT", "email"=>"lchambon@chu-grenoble.fr", "phone"=>"33 4 76 76 89 35"}], "overallOfficials"=>[{"name"=>"Leila Gofti Laroche, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"CHU Grenoble Alpes"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"No individual participant data sharing"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Grenoble", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University Grenoble Alps", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
