Gender Related Coping and Survivorship for Genitourinary Cancers

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT05649306
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Additional Education — OTHER
    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
  • Questionnaires — OTHER
    Female Sexual Function Index, Demoralization Scale-II
  • Attendance Diary — OTHER
    Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized

Study Details

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.

Key Dates

Start date
Jan 20, 2023
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Patients not receiving a cystectomy - Standard of Care Group
    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.
  • Arm: Patients not receiving a cystectomy - Additional Education Group
    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.
  • Arm: Patients receiving a cystectomy- Standard of Care Group
    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.
  • Arm: Patients receiving a cystectomy - Additional Education Group
    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 Measure

Use Demoralization Scale-II to assess change in demoralization [ Time Frame: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Riziki Covington
[email protected]
202-660-6133
Armine Smith
[email protected]
202-660-5561
Armine Smith, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Riziki Covington
[email protected]
202-660-6133
Armine K Smith
[email protected]
202-660-5561
Armine Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

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By specialty
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By research site
Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins Hospital· Baltimore, MD

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