Gender Related Coping and Survivorship for Genitourinary Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Questionnaires; Other: Additional Education; Other: Attendance Diary

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Meghan McNamara; Phone Number: 202-660-6133; Email: mmcnam11@jhmi.edu
• Study Contact Backup: Name: Armine Smith; Phone Number: 202-660-5561; Email: asmith165@jhmi.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
      • Principal Investigator: Armine Smith, MD
      • Contact: Riziki Covington; Phone Number: 202-660-6133; Email: rcoving5@jh.edu
      • Contact: Armine Smith; Phone Number: 202-660-5561; Email: asmit165@jhmi.edu
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Principal Investigator: Armine Smith, MD
      • Contact: Riziki Covington; Phone Number: 202-660-6133; Email: rcoving5@jh.edu
      • Contact: Armine K Smith; Phone Number: 202-660-5561; Email: asmit165@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Females Diagnosed with Non-Muscle Invasive Bladder Cancer and Muscle Invasive Bladder Cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaires; Female Sexual Function Index, Demoralization Scale-II
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.	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: 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
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.	Other: Questionnaires; Female Sexual Function Index, Demoralization Scale-II
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.	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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
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.	Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
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.	Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Armine Smith, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Adult; Female; Genitourinary Cancers
• Additional Relevant MeSH Terms: Urogenital Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Urogenital Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: IRB00314755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No