Gender Related Coping and Survivorship for Genitourinary Cancers
- Conditions
- Bladder Cancer
- Interventions
- Other: Additional EducationOther: QuestionnairesOther: Attendance Diary
- Registration Number
- NCT05649306
- Lead Sponsor
- Johns Hopkins University
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- Females with bladder cancer
- Willing to answer surveys regarding their psychosocial health and sexual health
- Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)
- Patients with cognitive impairments
- Women who are pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving a cystectomy - Additional Education Group Additional Education Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients not receiving a cystectomy - Additional Education Group Additional Education Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients receiving a cystectomy- Standard of Care Group Questionnaires Patients will receive standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients not receiving a cystectomy - Standard of Care Group Questionnaires Patients will receive standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients not receiving a cystectomy - Additional Education Group Attendance Diary Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients receiving a cystectomy - Additional Education Group Attendance Diary Patients will receive additional education with standard of care treatment. Patients will be asked to complete the Demoralization Scale II and Female Sexual Function Index at baseline, 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment. Patients will also be asked to complete an attendance diary documenting additional support services utilized. The Attendance Diary will be completed at 1-month following treatment, 3-months following treatment, 6-months following treatment, and one-year following treatment.
- Primary Outcome Measures
Name Time Method Use Demoralization Scale-II to assess change in demoralization Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment 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.
- Secondary Outcome Measures
Name Time Method Change in coping as assessed by Demoralization Scale II Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment 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.
Use Female Sexual Function Index (FSFI) to assess change in sexual function Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment 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.
Change in coping as assessed by the Female Sexual Function Index (FSFI) Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment 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.
Survivorship Baseline, 1-Month after treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment Assess survivorship in females with bladder cancer differs by stage of bladder cancer.
Trial Locations
- Locations (2)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States