Improving Sexual Health in Gynecologic Cancer Patients

Gynecologic Cancer Clinical Trial

Official title:

Improving Sexual Health in Gynecologic Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03827993
• Other study ID #: CASE14818
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• dedicated sexual health clinic appointment
Intervention will consist of a dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This provider will perform a focused history and physical, and 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual dysfunction as measured by FSFI	Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.	At 3, 6, 9, and 12 months from start of treatment
Secondary	Change in sexual distress as measured by FSDS	Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress participants are enduring related to their sexual dysfunction.	At 3, 6, 9, and 12 months from start of treatment
Secondary	Change in psychologic distress as measured by Kessler K10 Scale	Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the participants' coping throughout their illness. Scores range from 10 to 50 with higher scores indicating worse distress symptoms.	At 3, 6, 9, and 12 months from start of treatment
Secondary	Change in clinical assessment of vaginal symptoms as measured by VAS	Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health, with scores ranging from 0-12 and higher scores indicating worse symptoms.	At 3, 6, 9, and 12 months from start of treatment
Secondary	Change in clinical assessment of vulvar symptoms as measured by VuAS	Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health with scores ranging from 0-12 and higher scores indicating worse symptoms.	At 3, 6, 9, and 12 months from start of treatment