Clinical trial NCT05649306: Gender Related Coping and Survivorship for Genitourinary Cancers
Official title: Gender Related Coping and Survivorship for Genitourinary Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Female
Adult
Genitourinary Cancers
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females Diagnosed with Non-Muscle Invasive Bladder Cancer and Muscle Invasive Bladder Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Use Demoralization Scale-II to assess change in demoralization
timeFrame: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
Secondary outcomes:
measure: Use Female Sexual Function Index (FSFI) to assess change in sexual function
timeFrame: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
measure: Change in coping as assessed by Demoralization Scale II
timeFrame: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
measure: Change in coping as assessed by the Female Sexual Function Index (FSFI)
timeFrame: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
measure: Survivorship
timeFrame: Baseline, 1-Month after treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Armine Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: