[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05649306":3,"trial-entities:NCT05649306":126,"trial-summary:NCT05649306":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":51,"sex":65,"minimum_age":66,"maximum_age":24,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":76,"locations":79,"central_contacts":115,"overall_officials":121,"references":124,"see_also_links":125},"NCT05649306","IRB00314755","Gender Related Coping and Survivorship for Genitourinary Cancers","RECRUITING","2029-09","2025-10","2025-10-03","2023-01-20","Johns Hopkins University","OTHER",false,"This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected.","The Gender Related Coping and Survivorship Study for Genitourinary Cancers is focused on providing patients with additional education to promote sexual function in female bladder cancer patients with the aim to help decrease demoralization and sexual dysfunction. Patients receiving a cystectomy and patients not receiving a cystectomy will be randomized separately into an additional education or standard of care group. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. All participants will be asked to complete the Demoralization Scale-II and Female Sexual Function Index at baseline, one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment. Patients randomized to the additional education group will also be asked to complete an attendance diary one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment.",[18],"Bladder Cancer",[20,21,22],"Female","Adult","Genitourinary Cancers","OBSERVATIONAL",null,[],{"count":27,"type":28},80,"ESTIMATED",[30,36,42],{"type":13,"name":31,"description":32,"armGroupLabels":33},"Additional Education","Study-Specific Patient Handouts, Treating-Provider led counseling, Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and referrals for additional support services",[34,35],"Patients not receiving a cystectomy - Additional Education Group","Patients receiving a cystectomy - Additional Education Group",{"type":13,"name":37,"description":38,"armGroupLabels":39},"Questionnaires","Female Sexual Function Index, Demoralization Scale-II",[40,41],"Patients not receiving a cystectomy - Standard of Care Group","Patients receiving a cystectomy- Standard of Care Group",{"type":13,"name":43,"description":44,"armGroupLabels":45},"Attendance Diary","Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized",[34,35],[47],{"measure":48,"description":49,"timeFrame":50},"Use Demoralization Scale-II to assess change in demoralization","Evaluate educational interventions to improve demoralization in females with bladder cancer. The minimum score is 0 and the maximum score 32. Low scores are defined as 0-3, middle scores are defined between 4-10, and high scores are defined as ≥11.","Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment",[52,55,58,61],{"measure":53,"description":54,"timeFrame":50},"Use Female Sexual Function Index (FSFI) to assess change in sexual function","Evaluate if educational interventions improve sexual function in females with bladder cancer. The minimum total score for the FSFI is 2 and the maximum total score is 36. A higher score indicates increased sexual function.",{"measure":56,"description":57,"timeFrame":50},"Change in coping as assessed by Demoralization Scale II","Assess how coping in females with bladder cancer differs by stage of bladder cancer. For the Demoralization Scale II, the minimum score is 0 and the maximum score 32. Low scores are defined as 0-3, middle scores are defined between 4-10, and high scores are defined as ≥11.",{"measure":59,"description":60,"timeFrame":50},"Change in coping as assessed by the Female Sexual Function Index (FSFI)","Assess how coping in females with bladder cancer differs by stage of bladder cancer. The minimum total score for the FSFI is 2 and the maximum total score is 36. A higher score indicates increased sexual function.",{"measure":62,"description":63,"timeFrame":64},"Survivorship","Assess survivorship in females with bladder cancer differs by stage of bladder cancer.","Baseline, 1-Month after treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment","FEMALE","18 Years",{"inclusion":68,"exclusion":71,"raw_text":75},[69,70],"Females with bladder cancer","Willing to answer surveys regarding their psychosocial health and sexual health",[72,73,74],"Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)","Patients with cognitive impairments","Women who are pregnant","Inclusion Criteria:\n\n* Females with bladder cancer\n* Willing to answer surveys regarding their psychosocial health and sexual health\n\nExclusion Criteria:\n\n* Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)\n* Patients with cognitive impairments\n* Women who are pregnant",[77,78],"ADULT","OLDER_ADULT",[80,102],{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":99},"Sibley Memorial Hospital","Washington D.C.","District of Columbia","20016","United States",[87,92,96],{"name":88,"role":89,"phone":90,"email":91},"Riziki Covington","CONTACT","202-660-6133","rcoving5@jh.edu",{"name":93,"role":89,"phone":94,"email":95},"Armine Smith","202-660-5561","asmit165@jhmi.edu",{"name":97,"role":98},"Armine Smith, MD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},38.89511,-77.03637,{"facility":103,"status":7,"city":104,"state":105,"zip":106,"country":85,"contacts":107,"geoPoint":112},"Johns Hopkins Hospital","Baltimore","Maryland","21287",[108,109,111],{"name":88,"role":89,"phone":90,"email":91},{"name":110,"role":89,"phone":94,"email":95},"Armine K Smith",{"name":97,"role":98},{"lat":113,"lon":114},39.29038,-76.61219,[116,119],{"name":117,"role":89,"phone":90,"email":118},"Meghan McNamara","mmcnam11@jhmi.edu",{"name":93,"role":89,"phone":94,"email":120},"asmith165@jhmi.edu",[122],{"name":97,"affiliation":123,"role":98},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",[],[],{"nct_id":4,"conditions":127,"biomarkers":129},[128],"Bladder Carcinoma",[],{"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 is an observational study that will enroll 80 women with bladder cancer. Participants will be randomly assigned to either a standard care group or an education group.","completed","Gender Related Coping and Survivorship for Bladder Cancer","This study is looking at how women with bladder cancer cope and live with their disease, focusing on emotional distress and sexual health. Researchers want to see if extra education and support can help improve these areas. You would be asked to complete surveys about your mood and sexual function. Some participants will also receive extra educational materials, counseling, and referrals to support groups. The study aims to see if these additional resources can help reduce feelings of demoralization (a sense of hopelessness) and improve sexual function. This is an observational study, meaning researchers will gather information without giving new treatments. The study is currently unclear on its recruitment status and is looking for 80 women with bladder cancer.","Participants will be followed for one year after treatment, with assessments at 1, 3, 6, and 12 months.",119,"You would complete surveys about your mood and sexual health at the start, and then at 1, 3, 6, and 12 months after treatment. If you are in the education group, you would also complete attendance diaries for educational and support services.","Not stated in the trial record.",[],"v2"]