[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529235":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":24,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":24,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Stage 1: Tool Development","EXPERIMENTAL","Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))\u002FBehaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.",[13,14],"Other: Counseling Tool","Other: Questionnaires",{"label":16,"type":10,"description":17,"interventionNames":18},"Stage 1: Tool Implementation (Pilot Study)","Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Counseling Tool","Non-therapeutic educational intervention",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Questionnaires","Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.",[9,16],[30],"Surveys",[32],{"name":33,"affiliation":5,"role":34},"Daniel Kwon, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Daniel Avins","CONTACT","877-827-3222","Daniel.Avins@ucsf.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of California","RECRUITING","San Francisco","California","94143","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-122.41942,37.77493,{"lat":54,"lon":53},[57,58,60],{"name":37,"role":38,"phone":24,"phoneExt":24,"email":40},{"name":24,"role":38,"phone":39,"phoneExt":24,"email":59},"cancertrials@ucsf.edu",{"name":33,"role":34,"phone":24,"phoneExt":24,"email":24},{"type":62,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[64],{"name":65,"class":6},"Prostate Cancer Foundation","100529235","tumor-genomic-pre-test-counseling-tool-for-black-or-african-american-men-with-prostate-cancer-100529235",false,"NCT06171139","Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer","Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer","Inclusion Criteria:\n\nStage 1:\n\n1. Age 18-years-old or older\n2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.\n3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.\n4. Able to understand study procedures and to comply with them for the entire length of the study.\n5. Able to understand a written information sheet and willing to verbally consent.\n6. Fluent in English (reading, writing, and speaking)\n\nStage 2:\n\n1. Age 18-years-old or older\n2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.\n3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.\n4. Able to understand study procedures and to comply with them for the entire length of the study.\n5. Fluent in English (reading, writing, and speaking).\n6. Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:\n\n   1. Somatic DNA testing of already-collected tissue.\n   2. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.\n   3. Blood-based DNA testing to evaluate for circulating tumor DNA.\n7. Able to understand a written informed consent document and willing to sign it.\n\nExclusion Criteria:\n\nContraindication to any study-related procedure or assessment in either stage.","MALE","18 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"NA","The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.",[83,84],"Prostate Cancer","Prostate Cancer Metastatic","2026-04-14",{"date":87,"type":88},"2026-04-16","ACTUAL",{"date":90,"type":88},"2023-12-01",{"date":92,"type":77},"2027-08-31",{"name":5,"class":6},1]