Communication About Sexual Health in Gynecologic Cancer

Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention

The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.

The main questions it aims to answer are:

1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?

Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.

Participants will:

1. Fill out a consent form and survey
2. Have their next clinic visit audio recorded
3. Fill out another survey right after their clinic visit
4. Fill out a final survey 6 months after their clinic visit

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancers
• Intervention / Treatment: Behavioral: Sexual Health Resources; Behavioral: Starting the Conversation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer B Reese, PhD; Phone Number: 215-214-3223; Email: jennifer.reese@fccc.edu
• Study Contact Backup: Name: Kristen A Sorice; Phone Number: 215-214-1433; Email: kristen.sorice@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Kristen A Sorice; Phone Number: 215-214-1433; Email: kristen.sorice@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old
• Diagnosed with any stage (I-IV) gynecologic cancer
• Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
• Attending visits in follow-up care at Fox Chase Cancer Center
• Score of at least 3 on a sexual concerns screener question

Exclusion Criteria:

• Not able to speak English
• Not willing to have clinic visit audio recorded
• Eastern Cooperative Oncology Group (ECOG) score > 2
• Overt cognitive dysfunction or psychiatric disturbance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sexual Health Resources + Starting the Conversation Video/Workbook; Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion.	Behavioral: Sexual Health Resources; The sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer.; Behavioral: Starting the Conversation; Starting the Conversation includes a 25-minute video with information about sexual health and gynecologic cancer and tips about how to talk to their cancer care team about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills.
Active Comparator: Enhanced Care-as-Usual (Sexual Health Resources Alone); Participants will receive their usual care and a resource guide with information on sexual health and gynecologic cancer. The guide will include organizational resources and links to websites with information about sexual health and gynecologic cancer.	Behavioral: Sexual Health Resources; The sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Communication - Raise Topic of Sexual Health	Number of patients who raise the topic of sexual health concerns in a clinic visit.	2 weeks
Clinical Communication - Ask a Question about Sexual Health	Number of patients who ask a question about sexual health concerns in a clinic visit.	2 weeks
Clinical Communication - Express a Concern about Sexual Health	Number of patients who express a sexual health concern in a clinic visit.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Sexual Function	Patients' self-reported sexual function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SexFS Brief Profile Version 2.0. Four domains (lubrication, vaginal discomfort, satisfaction, and interest) will be scored. Domains are scored using T-scores, with higher scores signifying better sexual function for the lubrication, satisfaction, and interest domains. Lower scores in the vaginal discomfort range signify better sexual function.	Baseline, 2 weeks, 3 months, 6 months
Self-Reported Sexual Activity	Patients' self-reported sexual activity will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Activity screener. Number of participants reporting any sexual activity will be reported.	Baseline, 2 weeks, 3 months, 6 months
Self-Reported Anxiety Symptoms	Patients' self-reported anxiety symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety.	Baseline, 2 weeks, 3 months, 6 months
Self-Reported Depressive Symptoms	Patients' self-reported depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depressive symptoms.	Baseline, 2 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sexual health
• Other Study ID Numbers: 24-1010; R01CA285674 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No