Gender Related Coping and Survivorship for Genitourinary Cancers

NCT05649306 | Recruiting

• 1 other identifier: IRB00314755
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Female; Adult; Genitourinary Cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• Survivorship

  Baseline, 1-Month after treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment

Study Arms (4)

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

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; Other: Attendance Diary

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

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; Other: Attendance Diary

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

Patients not receiving a cystectomy - Additional Education Group; Patients receiving a cystectomy - Additional Education Group

Questionnaires OTHER

Female Sexual Function Index, Demoralization Scale-II

Patients not receiving a cystectomy - Standard of Care Group; Patients receiving a cystectomy- Standard of Care Group

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

Patients not receiving a cystectomy - Additional Education Group; Patients receiving a cystectomy - Additional Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Sibley Memorial Hospital

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

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urogenital Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Armine Smith, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan McNamara

CONTACT

202-660-6133; mmcnam11@jhmi.edu

Armine Smith

CONTACT

202-660-5561; asmith165@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 14, 2022
• Study Start: January 20, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)