Improving Sexual Health in Gynecologic Cancer Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2019 |
| Start Date: | April 24, 2019 |
| End Date: | June 30, 2020 |
| Contact: | Stephanie Ricci, MD |
| Email: | CancerCenterResearch@ccf.org |
| Phone: | 886-223-8100 |
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.
education and treatment for gynecologic cancer patients will improve patient outcomes as
compared to routine clinic visits.
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.
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.
Inclusion Criteria:
- Able to consent
- Screening positive for sexual health dysfunction as per baseline FSFI
- Diagnosed with any gynecologic malignancy
It is acceptable to have received treatment prior to or during enrollment, including prior
surgery, chemotherapy, radiation, hormonal therapy, or clinical trial.
Exclusion Criteria:
- Unable to speak English
- Patients unable to consent
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