Improving Sexual Health in Gynecologic Cancer Patients

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Gynecologic Cancer

Treatments: Behavioral: dedicated sexual health clinic appointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03827993

CASE14818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 2 patient groups

Routine surveillance

No Intervention group

Description:

Routine surveillance consists of attending gynecologic oncology office visits and being provided with an educational pamphlet discussing common sexual health concerns in gynecologic cancer patients, describing vaginal dilators, moisturizers, and lubrication. Resources for psychosocial counseling, physical therapy, and the sexual health clinic will be provided as well. Participants will have follow up at baseline, 3, 6, 9, and 12 months. Baseline visit consists of the initial visit where the Female Sexual Function Index (FSFI) screen was performed. Subsequent follow up visits will consist of FSFI, Female Sexual Distress Scale (FSDS), Kessler 10 surveys, and clinical assessment with Vaginal Assessment Scale and Vulvar Assessment Scale (VAS and VuAS).

Dedicated sexual health clinic appointment

Experimental group

Description:

Dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This will consist of the provider performing a focused history and physical, who will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required. The participants will follow up at 3, 6, 9, and 12 months after initial visit, either with the sexual health focused provider or their primary gynecologic oncologist, as determined by the needs of the participant per the provider.

Treatment:

Behavioral: dedicated sexual health clinic appointment