Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05649306

Conditions

Bladder Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Additional Education

Questionnaires

Attendance Diary

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT05649306

Start date

Jan 20, 2023

Status verified date

Oct, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females with bladder cancer
  • Willing to answer surveys regarding their psychosocial health and sexual health

Exclusion Criteria:

  • Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)
  • Patients with cognitive impairments
  • Women who are pregnant

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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

Questionnaires

Female Sexual Function Index, Demoralization Scale-II

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

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 and Locations

Central contacts

Meghan McNamara

202-660-6133mmcnam11@jhmi.edu

Armine Smith

202-660-5561asmith165@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Riziki Covington

202-660-6133rcoving5@jh.edu

Armine Smith

202-660-5561asmit165@jhmi.edu

Principal Investigator:

Armine Smith, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Riziki Covington

202-660-6133rcoving5@jh.edu

Armine K Smith

202-660-5561asmit165@jhmi.edu

Principal Investigator:

Armine Smith, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 3, 2025

Last verified

Oct, 2025

Keywords

  • Female
  • Adult
  • Genitourinary Cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-03.