Communication About Sexual Health in Gynecologic Cancer

NCT ID: NCT06904339

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2028-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Gynecologic Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Sexual Health Resources Alone

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.

Group Type ACTIVE_COMPARATOR

Sexual Health Resources

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Starting the Conversation

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer B Reese, PhD

Role: CONTACT

215-214-3223

Kristen A Sorice

Role: CONTACT

215-214-1433

Facility Contacts

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Kristen A Sorice

Role: primary

215-214-1433

Other Identifiers

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R01CA285674

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1010

Identifier Type: -

Identifier Source: org_study_id

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