[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07377006":3,"trial-entities:NCT07377006":127,"trial-summary:NCT07377006":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":83,"secondary_outcomes":88,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":101,"locations":104,"central_contacts":122,"overall_officials":123,"references":125,"see_also_links":126},"NCT07377006","2025-1272","Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer","Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital","NOT_YET_RECRUITING","2030-12-31","2026-02","2026-02-18","2026-10-01","M.D. Anderson Cancer Center","OTHER",false,"This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.","PRIMARY OBJECTIVES:\n\nI. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer.\n\nII. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community.\n\nIII. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas.\n\nSECONDARY OBJECTIVES:\n\nI. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas.\n\nII. Assess the change in completion of germline genetic testing with utilization of the decision support tool.\n\nOUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial.\n\nGROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool.\n\nGROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.\n\nGROUP 3: Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.",[19],"Prostate Carcinoma",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},108,"ESTIMATED",[29,47,56,61,65,73,77,80],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"BEHAVIORAL","Behavioral Intervention","View decision support tool",[34,35],"Group 2 (Draft decision support tool, cognitive interview)","Group 3 (Decision tool)",[37,38,39,40,41,42,43,44,45,46],"Behavior Conditioning Therapy","Behavior Modification","Behavior or Life Style Modifications","Behavior Therapy","Behavioral","Behavioral Interventions","Behavioral Modification","Behavioral Therapy","Behavioral Treatment","Behavioral Treatments",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[35],[53,54,55],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":14,"name":57,"description":58,"armGroupLabels":59},"Electronic Health Record Review","Ancillary studies",[60],"Group 1 (Qualitative interview)",{"type":14,"name":62,"description":63,"armGroupLabels":64},"Genetic Counseling","Meet with genetic counselor",[35],{"type":14,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Genetic Testing","Undergo standard of care genetic testing",[35],[70,71,72],"Genetic Analysis","Genetic Examination","Genetic Test",{"type":14,"name":74,"description":75,"armGroupLabels":76},"Interview","Complete qualitative interview",[60],{"type":14,"name":74,"description":78,"armGroupLabels":79},"Complete cognitive interview",[34],{"type":14,"name":81,"description":58,"armGroupLabels":82},"Survey Administration",[35],[84],{"measure":85,"description":86,"timeFrame":87},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",[],"MALE","18 Years",null,{"inclusion":93,"exclusion":98,"raw_text":100},[94,95,96,97],"Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital","Were recommended for germline genetic testing by their oncology provider","Can provide informed consent","Can communicate in English or Spanish",[99],"Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition","Inclusion Criteria:\n\n* Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital\n* Were recommended for germline genetic testing by their oncology provider\n* Can provide informed consent\n* Can communicate in English or Spanish\n\nExclusion Criteria:\n\n* Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition",[102,103],"ADULT","OLDER_ADULT",[105],{"facility":106,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":119},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[112,117],{"name":113,"role":114,"phone":115,"email":116},"Debanjan Pain","CONTACT","713-563-0020","DPain@mdanderson.org",{"name":113,"role":118},"PRINCIPAL_INVESTIGATOR",{"lat":120,"lon":121},29.76328,-95.36327,[],[124],{"name":113,"affiliation":13,"role":118},[],[],{"nct_id":4,"conditions":128,"biomarkers":129},[19],[],{"nct_id":4,"found":131,"summary":132,"prompt_version":142},true,{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This study plans to enroll 108 men and is an interventional study, meaning participants will receive a specific intervention. It is structured into three groups, with two observational and one pilot intervention group.","completed","Decision Support Tool for Prostate Cancer Genetic Testing","This study is looking at ways to help men with prostate cancer complete recommended germline genetic testing. Germline genetic testing checks for inherited gene changes that can affect your cancer treatment and help identify family members who might also be at risk. The study will develop and test a decision support tool, which is a resource designed to educate you and help you decide about genetic testing. Researchers want to understand what helps or hinders patients from getting tested and how well this new tool works to improve testing rates. The study involves men with prostate cancer receiving care at Lyndon B. Johnson (LBJ) Hospital who have been recommended for genetic testing by their doctor. The main goal is to see how safe the study procedures are over about one year.","Your safety and any side effects will be monitored through study completion, which is an average of one year.",131,"You might participate in interviews, view a draft or final decision support tool, and provide a blood sample. You will also meet with a genetic counselor and undergo standard genetic testing.","Not stated in the trial record.",[66],"v2"]