Clinical trial NCT03827993: Improving Sexual Health in Gynecologic Cancer Patients
Official title: Improving Sexual Health in Gynecologic Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sexual dysfunction as measured by FSFI
timeFrame: At 3, 6, 9, and 12 months from start of treatment
Secondary outcomes:
measure: Change in sexual distress as measured by FSDS
timeFrame: At 3, 6, 9, and 12 months from start of treatment
measure: Change in psychologic distress as measured by Kessler K10 Scale
timeFrame: At 3, 6, 9, and 12 months from start of treatment
measure: Change in clinical assessment of vaginal symptoms as measured by VAS
timeFrame: At 3, 6, 9, and 12 months from start of treatment
measure: Change in clinical assessment of vulvar symptoms as measured by VuAS
timeFrame: At 3, 6, 9, and 12 months from start of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Stephanie Ricci, MD
role: PRINCIPAL_INVESTIGATOR
References: