NCT05649306

Gender Related Coping and Survivorship for Genitourinary Cancers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	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
OTHER	Questionnaires	Female Sexual Function Index, Demoralization Scale-II
OTHER	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

Timeline

• Start date: 2023-01-20
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2022-12-14
• Last updated: 2025-10-03

Locations

2 sites across 1 country: United States