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Recruiting

NCT Number: NCT06904339

Communication About Sexual Health in Gynecologic Cancer

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

Recruiting

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Key information

Conditions

Gynecologic Cancers

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location status: Recruiting

Location contact

Kristen A Sorice

CONTACT

[email protected]

215-214-1433

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Clinical Communication - Raise Topic of Sexual Health

    Time frame: 2 weeks

    Number of patients who raise the topic of sexual health concerns in a clinic visit.

  2. Clinical Communication - Ask a Question about Sexual Health

    Time frame: 2 weeks

    Number of patients who ask a question about sexual health concerns in a clinic visit.

  3. Clinical Communication - Express a Concern about Sexual Health

    Time frame: 2 weeks

    Number of patients who express a sexual health concern in a clinic visit.

Secondary outcomes

  1. Self-Reported Sexual Function

    Time frame: Baseline, 2 weeks, 3 months, 6 months

    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.

  2. Self-Reported Sexual Activity

    Time frame: Baseline, 2 weeks, 3 months, 6 months

    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.

  3. Self-Reported Anxiety Symptoms

    Time frame: Baseline, 2 weeks, 3 months, 6 months

    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.

  4. Self-Reported Depressive Symptoms

    Time frame: Baseline, 2 weeks, 3 months, 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer B Reese, PhD

CONTACT

[email protected]

215-214-3223

Kristen A Sorice

CONTACT

[email protected]

215-214-1433

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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