Communication About Sexual Health in Gynecologic Cancer

Temple University Health System (TUHS)

Status: Enrolling

Conditions: Gynecologic Cancers

Treatments: Behavioral: Starting the Conversation; Behavioral: Sexual Health Resources

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06904339

24-1010

R01CA285674 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Sexual Health Resources Alone

Active Comparator group

Description:

Participants will receive 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.

Treatment:

Behavioral: Sexual Health Resources

Sexual Health Resources + Starting the Conversation Video/Workbook

Experimental group

Description:

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.

Treatment:

Behavioral: Sexual Health Resources

Behavioral: Starting the Conversation