[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576710":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":167,"collaborators":170,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":197,"minAge":198,"maxAge":18,"enrollmentInfo":199,"targetDuration":18,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prehabilitation","EXPERIMENTAL","The prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery).",[13],"Behavioral: Multimodal prehabilitation Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Multimodal prehabilitation Program","A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase.\n\nBased on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and\u002For nutrition optimization, and\u002For distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effects. The duration of the program will be set at a minimum of three weeks.",[9],[26],{"name":27,"affiliation":28,"role":29},"Marina Pieri, Medical Doctor","IRCCS Ospedale San Raffaele","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Marina LG Pieri, Medical Doctor","CONTACT","+393334625052","pieri.marina@hsr.it",[37,55,70,84,98,112,126,140,154],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":41,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Policlinico Universitario AOU Renato Dulbecco di Catanzaro","RECRUITING","Catanzaro","Italy","88100","IT",{"type":45,"coordinates":46},"Point",[47,48],16.60086,38.88247,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":18,"email":54},"Eugenio Garofalo, Professor","+393498125841","eugenio.garofalo@gmail.com",{"facility":56,"status":57,"city":58,"state":41,"zip":59,"country":41,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"AOU Careggi","NOT_YET_RECRUITING","Florence","50134",{"type":45,"coordinates":61},[62,63],11.24626,43.77925,{"lat":63,"lon":62},[66],{"name":67,"role":33,"phone":68,"phoneExt":18,"email":69},"Gabriele Baldini, Professor","+393333196036","gabriele.baldini@unifi.it",{"facility":71,"status":57,"city":72,"state":41,"zip":73,"country":41,"countryCode":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Ospedale Galliera di Genova","Genova","16128",{"type":45,"coordinates":75},[76,77],11.87211,45.21604,{"lat":77,"lon":76},[80],{"name":81,"role":33,"phone":82,"phoneExt":18,"email":83},"Claudia Brusasco, Doctor","+393291185009","claudia.brusasco@gmail.com",{"facility":85,"status":57,"city":86,"state":41,"zip":87,"country":41,"countryCode":43,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"ASSTN GOM Niguarda","Milan","20162",{"type":45,"coordinates":89},[90,91],12.59836,42.78235,{"lat":91,"lon":90},[94],{"name":95,"role":33,"phone":96,"phoneExt":18,"email":97},"Monica Gualtierotti, Doctor","+390264447918","monica.gualtierotti@ospedaleniguarda.it",{"facility":99,"status":57,"city":100,"state":41,"zip":101,"country":41,"countryCode":43,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"IRCCS Ospedale San Gerardo dei Tintori","Monza","20900",{"type":45,"coordinates":103},[104,105],9.27246,45.58005,{"lat":105,"lon":104},[108],{"name":109,"role":33,"phone":110,"phoneExt":18,"email":111},"Luca C Nespoli, Professor","+393201797391","luca.nespoli@unimib.it",{"facility":113,"status":39,"city":114,"state":41,"zip":115,"country":41,"countryCode":43,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Ospedale Vanvitelli di Napoli","Naples","80129",{"type":45,"coordinates":117},[118,119],14.26811,40.85216,{"lat":119,"lon":118},[122],{"name":123,"role":33,"phone":124,"phoneExt":18,"email":125},"Pasquale Sansone, Professor","+393384969395","pasquale.sansone@unicampania.it",{"facility":127,"status":57,"city":128,"state":41,"zip":129,"country":41,"countryCode":43,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"AOPD Padova","Padova","35128",{"type":45,"coordinates":131},[132,133],11.14261,44.38225,{"lat":133,"lon":132},[136],{"name":137,"role":33,"phone":138,"phoneExt":18,"email":139},"Nicola Passuello, Doctor","+393482245159","nicola.passuello@aopd.veneto.it",{"facility":141,"status":57,"city":142,"state":41,"zip":143,"country":41,"countryCode":43,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Azienda sanitaria universitaria Friuli Centrale (ASU FC)","Udine","33100",{"type":45,"coordinates":145},[146,147],13.23715,46.0693,{"lat":147,"lon":146},[150],{"name":151,"role":33,"phone":152,"phoneExt":18,"email":153},"Tiziana Bove, Professor","+393474785763","tiziana.bove@asufc.sanita.fvg.it",{"facility":28,"status":39,"city":86,"state":86,"zip":155,"country":41,"countryCode":43,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"20132",{"type":45,"coordinates":157},[158,159],9.18951,45.46427,{"lat":159,"lon":158},[162,166],{"name":163,"role":33,"phone":164,"phoneExt":165,"email":35},"Marina Pieri, MD","0226438173","+39",{"name":163,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":29,"investigatorFullName":168,"investigatorTitle":169,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marina Pieri","Doctor",[171,174,176,178,180,182,184,186],{"name":172,"class":173},"Prof. Pasquale Sansone","UNKNOWN",{"name":175,"class":173},"Prof. Eugenio Garofalo",{"name":177,"class":173},"Prof. Tiziana Bove",{"name":179,"class":173},"Dr. Claudia Brusasco",{"name":181,"class":173},"Prof. Gabriele Baldini",{"name":183,"class":173},"Dr. Nicola Passuello",{"name":185,"class":173},"Dr. Monica Gualtierotti",{"name":187,"class":173},"Prof. Luca Carlo Nespoli","100576710","multimodal-prehabilitation-in-cancer-surgery-100576710",false,"NCT06788834","Multimodal Prehabilitation in Cancer Surgery","Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial","PROPOSE-RCT","Inclusion Criteria:\n\n* Adult patient (age \\> 18 years);\n* Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;\n* Signed informed consent.\n\nExclusion Criteria:\n\nA) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:\n\n* Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);\n* Severe\u002Fend-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \\\u003C50% pred, end-stage kidney or liver disease);\n* American Society of Anesthesiologists (ASA) physical status classes 4-5;\n* Disabling orthopedic and neuromuscular disease;\n* Psychosis, dementia;\n* Symptomatic anemia with a hemoglobin value \\\u003C 7 gr\u002Fdl.\n\nB) Patients with both optimal functional capacity (a Duke activity status index \\[DASI\\] score \\> 45) and optimal nutritional status (NRS-nutrition screening tool-score \\\u003C 2).",true,"ALL","18 Years",{"count":200,"type":201},400,"ESTIMATED","INTERVENTIONAL",[204],"NA","The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.\n\nThe multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.",[207],"Cancer Surgery",[9,209,210,211,212,213,214,215,216,217,218],"Functional recovery","Relaxation","Exercise","Diet","Nutrition","Functional walking","Hospital stay","Multimodal prehabilitation program","Standard treatment","Anesthesiology","2025-08-05",{"date":221,"type":222},"2025-08-07","ACTUAL",{"date":224,"type":222},"2025-01-30",{"date":226,"type":201},"2026-09",{"name":5,"class":6},9]