[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":12,"centralContacts":30,"locations":39,"responsibleParty":61,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Usual preoperative care prior to radical cystectomy",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention","EXPERIMENTAL","Preoperative pre-habilitation",[18,19],"Behavioral: Pre-operative physical exercise","Behavioral: Pre-operative mindfulness meditation practice",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"BEHAVIORAL","Pre-operative physical exercise","Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.",[14],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"Pre-operative mindfulness meditation practice","Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.",[14],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Christine Ibilibor","CONTACT","4349240871","ci5d@virginia.edu",{"name":37,"role":33,"phone":34,"phoneExt":12,"email":38},"Francesca Whitefield","fbw3mg@virginia.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Charlottesville","Virginia","22903","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.47668,38.02931,{"lat":51,"lon":50},[54,56,59],{"name":32,"role":33,"phone":12,"phoneExt":12,"email":55},"CI5D@virginia.edu",{"name":57,"role":33,"phone":12,"phoneExt":12,"email":58},"Ashley Byrne","aeb6q@uvahealth.org",{"name":60,"role":33,"phone":12,"phoneExt":12,"email":12},"Christine Ibilibor, MD",{"type":62,"investigatorFullName":60,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Assistant Professor",[65,67],{"name":66,"class":6},"American Cancer Society, Inc.",{"name":68,"class":69},"Integrated Translational Health Research Institute of Virginia (iTHRIV)","UNKNOWN","100500022","pre-habilitation-with-mindfulness-and-exercise-for-patients-undergoing-radical-cystectomy-primer-trial-100500022",false,"NCT05790850","Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)","PRIMER","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥18 years of age\n* Good surgical candidate determined by treating surgeon\n* Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology\n* Adequate Organ Function per protocol definition\n* ECOG performance status ≤2\n* Received medical clearance to complete cardiopulmonary exercise testing\n* Willing to use the personal or study provided devices for monitoring and performing the exercise routines.\n* Fluent in English or Spanish for the EORTC QLQ questionnaire\n* No known contraindications to high intensity exercise\n\nExclusion Criteria:\n\n* Contraindications to participating in aerobic exercise\n* Currently participating in an aerobic exercise program\n* New onset chest pain nor dyspnea with exertion\n* Histologically documented micropapillary or sarcomatoid bladder cancer\n* Distant metastatic carcinoma","ALL","18 Years","90 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.",[88,89,90],"Bladder Cancer","Non-muscle-invasive Bladder Cancer","Muscle-Invasive Bladder Carcinoma",[92,93,94,95],"Mindfulness","Meditation","Physical Exercise","Pre-habilitation","2024-12-10",{"date":98,"type":99},"2024-12-16","ACTUAL",{"date":101,"type":99},"2023-03-30",{"date":103,"type":82},"2026-06",{"name":5,"class":6},1]