[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562844":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":68,"studyPopulation":57,"armGroups":69,"interventions":82,"overallOfficials":57,"centralContacts":90,"locations":100,"responsibleParty":117,"collaborators":57,"id":119,"slug":57,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":57,"enrollmentInfo":128,"targetDuration":57,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":57,"overallStatus":102,"whyStopped":57,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":57},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Complications","Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)","7-10 days after surgery",{"measure":10,"description":14,"timeFrame":15},"Number of complications (i.e. axyllary web syndrome; lymphedema)","2 months after surgery",{"measure":10,"description":14,"timeFrame":17},"6 months after surgery",[19,23,24,25,26,29,31,32,33,36,37,38,39,42,43,44,45,48,49,50,51,54,55,56],{"measure":20,"description":21,"timeFrame":22},"Upper limb pain","Pain assessed through the numeric pain rating scale (0-10)","before surgery",{"measure":20,"description":21,"timeFrame":12},{"measure":20,"description":21,"timeFrame":15},{"measure":20,"description":21,"timeFrame":17},{"measure":27,"description":28,"timeFrame":22},"Neck Disability","Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability)",{"measure":27,"description":30,"timeFrame":12},"Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)",{"measure":27,"description":30,"timeFrame":15},{"measure":27,"description":30,"timeFrame":17},{"measure":34,"description":35,"timeFrame":22},"Upperlimb Disability","Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)",{"measure":34,"description":35,"timeFrame":12},{"measure":34,"description":35,"timeFrame":15},{"measure":34,"description":35,"timeFrame":17},{"measure":40,"description":41,"timeFrame":22},"Self-reported Quality of life","Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)",{"measure":40,"description":41,"timeFrame":12},{"measure":40,"description":41,"timeFrame":15},{"measure":40,"description":41,"timeFrame":17},{"measure":46,"description":47,"timeFrame":22},"Joint range of motion","upper limb and cervical range of motion assessed through digital goniometer",{"measure":46,"description":47,"timeFrame":12},{"measure":46,"description":47,"timeFrame":15},{"measure":46,"description":47,"timeFrame":17},{"measure":52,"description":53,"timeFrame":22},"Muscle strength","handgrip, shoulder and neck muscle strength assessed through handheld dynamometer",{"measure":52,"description":53,"timeFrame":12},{"measure":52,"description":53,"timeFrame":15},{"measure":52,"description":53,"timeFrame":17},null,{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":57,"timePerspective":57,"maskingInfo":63},"RANDOMIZED","PARALLEL","Non-profit blinded randomized controlled interventional single-center pilot study.","TREATMENT",{"masking":64,"maskingDescription":65,"whoMasked":66},"SINGLE","the evaluators do not know the treatment group of the patients.",[67],"OUTCOMES_ASSESSOR","Breast cancer is the most common malignancy in women worldwide. Advances in early detection and improved treatment of breast cancer have led to increased survival after diagnosis, resulting in many more women living with the consequences of cancer treatment.\n\nBreast cancer surgeries and treatments can cause arm morbidity that can progress beyond 2.5 years.\n\nThe most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit.\n\nOther complications include postoperative axillary web syndrome (AWS), which can cause pain and movement limitations; lymphedema reported with a prevalence of 6-52% especially after axillary lymph node dissection (ALND); kinematic alterations that may promote future development of rotator cuff disease; scapulohumeral dyskinesia, proprioception deficit, postural alterations and reduced quality of life.\n\nThere is scientific evidence in the literature to suggest that early postoperative exercise is safe and can improve shoulder function; however, uncertainty remains about the optimal content, timing, and cost-effectiveness of exercise interventions.\n\nThe study aims to verify the effectiveness of a rehabilitation treatment in terms of prevention of possible complications following breast cancer surgery.\n\nPrimary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures.\n\nSecondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"Telerehabilitation","EXPERIMENTAL","In the days following surgery, intervention group will receive a structured rehabilitation session by a physiotherapist. In this session, two booklets will be provided to the patients, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid their possible onset through the demonstration of exercises to be carried out at home, self-massage techniques of the scar, behaviors and lifestyle to be adopted immediately after surgery.\n\nThis group will carry out, starting from 10 days post-surgery, a home tele-rehabilitation intervention from Monday to Friday via the TeleHab device (Vald Performance) until 2 months after surgery.\n\nExercises for ROM recovery and strength recovery will be carried out three days a week and only exercises for ROM recovery will be carried out two days a week.",[75],"Other: Telerehabilitation",{"label":77,"type":78,"description":79,"interventionNames":80},"Standard care","ACTIVE_COMPARATOR","Standard care consists of the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out which generally consists of the delivery of two booklets, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid its possible onset through the demonstration of exercises to be carried out at home, self-massage techniques for the scar, behaviors and lifestyle to be adopted immediately after surgery.",[81],"Other: Standard Care",[83,86],{"type":6,"name":71,"description":84,"armGroupLabels":85,"otherNames":57},"The telerehabilitation intervention will begin from 10 days post-surgery, the operation will be carried out at home from Monday to Friday via the TeleHab device (Vald Performance) up to 2 months after the surgery.\n\nExercises for ROM recovery and strength recovery will be carried out three days a week and only exercises for ROM recovery will be carried out two days a week. The progression of the exercises will be carried out taking into account the pain and fatigue recorded by the patient at the end of each exercise session.",[71],{"type":6,"name":87,"description":88,"armGroupLabels":89,"otherNames":57},"Standard Care","Standard care intervention follow the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out. It consists of the delivery of two booklets, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid its possible onset through the demonstration of exercises to be carried out at home, self-massage techniques for the scar, behaviors and lifestyle to be adopted immediately after surgery.",[77],[91,96],{"name":92,"role":93,"phone":94,"phoneExt":57,"email":95},"Silvia Sterzi, MD","CONTACT","+390622541624","s.sterzi@policlinicocampus.it",{"name":97,"role":93,"phone":98,"phoneExt":57,"email":99},"Marco Bravi, DPT","+390622541646","m.bravi@policlinicocampus.it",[101],{"facility":5,"status":102,"city":103,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"RECRUITING","Roma","00128","Italy","IT",{"type":108,"coordinates":109},"Point",[110,111],11.10642,44.99364,{"lat":111,"lon":110},[114,115],{"name":97,"role":93,"phone":94,"phoneExt":57,"email":57},{"name":116,"role":93,"phone":94,"phoneExt":57,"email":57},"Fabio Santacaterina, DPT",{"type":118,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100562844",false,"NCT06608446","Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery","Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial","LINFO","Inclusion Criteria:\n\n* diagnosis of breast cancer\n* Having undergone quadrantectomy or mastectomy surgery\n* Age \\> 18 years\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Neurological deficits with sensorimotor impairment of the upper limb\n* Cognitive deficits that prevent the completion of questionnaires (MMSE\\>24)","FEMALE","18 Years",{"count":129,"type":130},155,"ESTIMATED","INTERVENTIONAL",[133],"NA","The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit.\n\nThe study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery.\n\nPrimary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures.\n\nSecondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.",[136],"Breast Neoplasms","2026-04-16",{"date":139,"type":140},"2026-04-21","ACTUAL",{"date":142,"type":140},"2023-05-15",{"date":144,"type":130},"2026-07-30",{"name":5,"class":6},1]