Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649306
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2022-12-01
Brief Title:
Gender Related Coping and Survivorship for Genitourinary Cancers
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Gender Related Coping and Survivorship for Genitourinary Cancers
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None