[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441088":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":53,"collaborators":55,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardio-Oncology Rehabilitation (CORE)","EXPERIMENTAL","Participants in the CORE group will have\n\n1. A personalized, supervised exercise program ((in-person at intuition and virtual\u002F homebased exercises)\n2. CV risk factor management,\n3. behavioural support for the first 6 months. The behavioural support will continue for CORE participants from months 7-24. Behavioural support includes professionally guided and peer-enhanced exercise behavioural support based on behaviour change stage theories.\n\nCORE participants will be provided a wrist-worn heart and physical activity monitor to use throughout the 24-month observation period.",[13],"Behavioral: Cardio-oncology Rehabilitation (CORE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care (CON)","NO_INTERVENTION","Participants in the CON group will receive standard medical care and physical activity will be monitored by a wrist-worn activity tracker for 2 years.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Cardio-oncology Rehabilitation (CORE)","Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Paaladinesh Thavendiranathan, MD","CONTACT","416-340-5326","dinesh.thavendiranathan@uhn.ca",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Nilina Mohabir, MSc","437-677-7491","nilina.mohabir@uhn.ca",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Health Network","RECRUITING","Toronto","Ontario","M5G2C4","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.39864,43.70643,{"lat":48,"lon":47},[51],{"name":27,"role":28,"phone":18,"phoneExt":18,"email":52},"Dinesh.Thavendiranathan@uhn.ca",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[56,58,60,62,64,66,68,70,72],{"name":57,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)",{"name":59,"class":6},"Queen Elizabeth II Health Sciences Centre",{"name":61,"class":6},"Alberta Health services",{"name":63,"class":6},"Vancouver General Hospital",{"name":65,"class":6},"Université de Montréal",{"name":67,"class":6},"Dalhousie University",{"name":69,"class":6},"University of Alberta",{"name":71,"class":6},"University of British Columbia",{"name":73,"class":6},"University of Toronto","100441088","the-himalayas-trial-and-lifestyle-changes-in-pediatric-adolescent-and-young-adult-cancer-survivors-study-a-multicentre-randomized-controlled-trial-100441088",false,"NCT05023785","The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial","The Harmonized Interventions to Maintain Health Via Appropriate Risk Factor Modification and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial","HIMALAYAS","Inclusion Criteria:\n\n1. Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;\n2. Be 18-45 years of age at the time of enrolment;\n3. Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);\n4. Be cancer-free at the time of enrollment;\n5. Stage B Heart Failure (SBHF)\n\n   * In patients with availability of pre-treatment imaging:\n\n     * ≥10% decrease in LVEF at post-treatment compared to pre-treatment\n     * ≥15% decrease in GLS at post-treatment compared to pre-treatment\n   * No pre-treatment imaging:\n\n     * LVEF ≤53% in women\u002F51% in men\n     * GLS \\>-18%\n     * Left ventricular hypertrophy (LV mass\u002Fbody surface area: \\>95 g\u002Fm2 for women or \\>115 g\u002Fm2 for men)\n     * Concentric remodelling (\\>0.42 relative wall thickness)\n     * Diastolic dysfunction (≥ grade 1)\n     * BNP ≥35pg\u002Fml or NT-proBNP ≥125pg\u002Fml\n\nExclusion Criteria:\n\n1. Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;\n2. Have an untreated physical or mental health concern that precludes safe and effective exercise participation;\n3. Have established CVD (excluding mildly reduced LVEF as described above);\n4. Be pregnant at time of recruitment;\n5. Be currently engaging in frequent high-intensity exercise (\\>1 high-intensity exercise session per week);\n6. Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.","ALL","18 Years","45 Years",{"count":86,"type":87},336,"ESTIMATED","INTERVENTIONAL",[90],"NA","Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression). A reduction of physical activity levels can evoke functional limitations resulting in a vicious cycle of reduced exercise tolerance and physical deterioration. To date, there is limited evidence on the use of non-pharmacological strategies such as Cardio-Oncology Rehabilitation (CORE) including structured exercise, behavioural support and risk factor management to improve the outcomes of this underserved population. The HIMALAYAS study is a randomized controlled trial designed to evaluate the impact of a CORE intervention (consisting of six-months home and onsite-based structured moderate to high-intensity aerobic exercise training and CVD risk factor management) on CV and psychosocial health, and the cardiovascular disease risk in PAYA-CS with mild heart dysfunction (stage B heart failure) compared to standard of care (i.e. providing guidance on the current exercise recommendations for cancer survivors). The primary objective of the HIMALAYAS study is to determine whether a six-month supervised CORE intervention, consisting of individualized moderate to high-intensity aerobic exercise training, CVD risk factor modification and enhanced online behavioral support, improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and patient-reported outcomes (PROs) at six- months follow-up compared to standard of care (CON) in PAYA-CS with stage B heart failure. The secondary objective is to assess the same outcomes at 12- and 24-months follow-up. We will recruit 336 patients across 5 sites in Canada and upto 134 patients at UHN in 3 years and conclude in 6 years.",[93,94,95],"Heart Failure","Cardiotoxicity","Cancer",[97,98,99,100,101],"Adolescents and Young Adults","Exercise Therapy","Behavioral and Peer Support","Cardiac Rehabilitation","Cancer Survivor","2025-11-25",{"date":104,"type":105},"2025-11-26","ACTUAL",{"date":107,"type":105},"2024-01-01",{"date":109,"type":87},"2027-03",{"name":5,"class":6},1]