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Trial Title:
Gender Related Coping and Survivorship for Genitourinary Cancers
NCT ID:
NCT05649306
Condition:
Bladder Cancer
Conditions: Official terms:
Urogenital Neoplasms
Conditions: Keywords:
Female
Adult
Genitourinary Cancers
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Additional Education
Description:
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
Arm group label:
Patients not receiving a cystectomy - Additional Education Group
Arm group label:
Patients receiving a cystectomy - Additional Education Group
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Female Sexual Function Index, Demoralization Scale-II
Arm group label:
Patients not receiving a cystectomy - Standard of Care Group
Arm group label:
Patients receiving a cystectomy- Standard of Care Group
Intervention type:
Other
Intervention name:
Attendance Diary
Description:
Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer
Educational Series, and additional educational and support services utilized
Arm group label:
Patients not receiving a cystectomy - Additional Education Group
Arm group label:
Patients receiving a cystectomy - Additional Education Group
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.
Criteria for eligibility:
Study pop:
Females Diagnosed with Non-Muscle Invasive Bladder Cancer and Muscle Invasive Bladder
Cancer
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Riziki Covington
Phone:
202-660-6133
Email:
rcoving5@jh.edu
Contact backup:
Last name:
Armine Smith
Phone:
202-660-5561
Email:
asmit165@jhmi.edu
Investigator:
Last name:
Armine Smith, MD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Riziki Covington
Phone:
202-660-6133
Email:
rcoving5@jh.edu
Contact backup:
Last name:
Armine K Smith
Phone:
202-660-5561
Email:
asmit165@jhmi.edu
Investigator:
Last name:
Armine Smith, MD
Email:
Principal Investigator
Start date:
January 20, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05649306
