Communication About Sexual Health in Gynecologic Cancer

NCT06904339 | Recruiting

• 2 other identifiers: 24-1010R01CA285674
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecologic Cancers

Keywords

sexual health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Self-Reported Sexual Function

  Baseline, 2 weeks, 3 months, 6 months

• Self-Reported Sexual Activity

  Baseline, 2 weeks, 3 months, 6 months

• Self-Reported Anxiety Symptoms

  Baseline, 2 weeks, 3 months, 6 months

• Self-Reported Depressive Symptoms

  Baseline, 2 weeks, 3 months, 6 months

Study Arms (2)

Enhanced Care-as-Usual (Sexual Health Resources Alone)

ACTIVE COMPARATOR

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

Sexual Health Resources + Starting the Conversation Video/Workbook

EXPERIMENTAL

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: Starting the Conversation; Behavioral: Sexual Health Resources

Interventions

Starting the Conversation BEHAVIORAL

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.

Sexual Health Resources + Starting the Conversation Video/Workbook

Sexual Health Resources BEHAVIORAL

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.

Enhanced Care-as-Usual (Sexual Health Resources Alone); Sexual Health Resources + Starting the Conversation Video/Workbook

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Central Study Contacts

Jennifer B Reese, PhD

CONTACT

215-214-3223; jennifer.reese@fccc.edu

Kristen A Sorice

CONTACT

215-214-1433; kristen.sorice@fccc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 1, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)