Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-22 @ 9:14 PM
Study NCT ID:
NCT03827993
Status:
TERMINATED
Last Update Posted:
2022-06-28
First Post:
2019-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sexual Health in Gynecologic Cancer Patients
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Improving Sexual Health in Gynecologic Cancer Patients
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.
Detailed Description:
Participants will be randomly placed to one of two groups. This random placement allows our research study to be more significant when the study team checks the results. In one group, the "control" group, participants will attend their usual clinic visits with their provider every 3 months for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time.
In the other group, the "intervention" group, participants will attend one focused Sexual Health Clinic visit, where a provider specialized in sexual health for cancer patients will review a focused history and physical, and will provide education, as well as recommend any helpful treatments.
This provider may or may not recommend follow up with her again after this initial visit. Participants will otherwise continue the usual every 3 month clinic visits with their Gynecologic Oncologist for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. Participants will not need any additional blood draws or procedures. During their gynecologic exam, a swab will be collected to test participants vaginal pH - a test to see the health of their vaginal flora.
In brief, participants will have their usual 4 clinic visits: one at 3 months, 6 months, 9 months, and 12 months. At each visit, participants will fill out 3 surveys and have a gynecologic exam performed as they usually would, but with a vaginal swab for vaginal pH. This swab will be assessed in the clinic by their provider as the swab will change colors to show pH at the time of exam. This result will be noted in the participants' chart and the swab will be discarded.
In the other group, the "intervention" group, participants will attend one focused Sexual Health Clinic visit, where a provider specialized in sexual health for cancer patients will review a focused history and physical, and will provide education, as well as recommend any helpful treatments.
This provider may or may not recommend follow up with her again after this initial visit. Participants will otherwise continue the usual every 3 month clinic visits with their Gynecologic Oncologist for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. Participants will not need any additional blood draws or procedures. During their gynecologic exam, a swab will be collected to test participants vaginal pH - a test to see the health of their vaginal flora.
In brief, participants will have their usual 4 clinic visits: one at 3 months, 6 months, 9 months, and 12 months. At each visit, participants will fill out 3 surveys and have a gynecologic exam performed as they usually would, but with a vaginal swab for vaginal pH. This swab will be assessed in the clinic by their provider as the swab will change colors to show pH at the time of exam. This result will be noted in the participants' chart and the swab will be discarded.
Study Oversight
Has Oversight DMC:
True
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?: