Improving Sexual Health in Gynecologic Cancer Patients

NCT03827993 | Terminated DMC

• 1 other identifier: CASE14818
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in sexual distress as measured by FSDS

  At 3, 6, 9, and 12 months from start of treatment

• Change in psychologic distress as measured by Kessler K10 Scale

  At 3, 6, 9, and 12 months from start of treatment

• Change in clinical assessment of vaginal symptoms as measured by VAS

  At 3, 6, 9, and 12 months from start of treatment

• Change in clinical assessment of vulvar symptoms as measured by VuAS

  At 3, 6, 9, and 12 months from start of treatment

Study Arms (2)

Routine surveillance

NO INTERVENTION

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

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.

Behavioral: dedicated sexual health clinic appointment

Interventions

dedicated sexual health clinic appointment BEHAVIORAL

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.

Dedicated sexual health clinic appointment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to speak English
• Patients unable to consent

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Stephanie Ricci, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: July 22, 2019
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)