Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06904339

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

Led by Fox Chase Cancer Center · Updated on 2026-06-02

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

F

Fox Chase Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial focuses on women diagnosed with gynecologic cancers to evaluate whether an educational video and workbook can help patients communicate better with their cancer care providers about sexual health concerns. The study compares patients who receive both the educational program and a resource booklet to those who receive the resource booklet alone alongside their usual care. Researchers aim to find out if the educational program leads to more conversations about sexual health and improvements in sexual function, anxiety, and depression. Participants will be randomly assigned to one of two groups. One group will receive their usual care plus a sexual health resource guide containing information and links about sexual health and gynecologic cancer. The other group will receive the same resource guide plus a 25-minute educational video and a workbook with activities designed to help them practice communication skills and prepare for discussions with their cancer care providers. During the study, participants will complete surveys at different times: before the study, immediately after their next clinic visit, and six months later. Their clinic visits will be audio recorded to assess conversations about sexual health. Researchers will measure how often participants raise sexual health topics, ask questions, and express concerns during clinical visits. They will also track self-reported sexual function, sexual activity, anxiety, and depression over six months to evaluate the effects of the educational program.

CONDITIONS

Brief Title

Communication About Sexual Health in Gynecologic Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 follow-up care visits at Fox Chase Cancer Center
  • Score of at least 3 on a sexual concerns screener question
Not Eligible

You will not qualify if you...

  • Unable to speak English
  • Unwilling to have clinic visit audio recorded
  • Eastern Cooperative Oncology Group (ECOG) score greater than 2
  • Overt cognitive dysfunction or psychiatric disturbance

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Behavioral Intervention

Duration - 2 weeks

Participants receive sexual health resources and may watch a 25-minute video with information about sexual health and gynecologic cancer. They will also complete a workbook with activities to help practice communication skills about sexual health concerns.

1 baseline visit and 1 follow-up visit

Follow-up Assessments

Duration - 6 months

Participants complete self-reported assessments on sexual function, sexual activity, anxiety symptoms, and depressive symptoms at multiple timepoints to monitor changes over time.

Visits at 2 weeks, 3 months, and 6 months post-intervention

Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

J

Jennifer B Reese, PhD

K

Kristen A Sorice

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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