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Recruiting NCT06904339

Communication About Sexual Health in Gynecologic Cancer

No phase Interventional Gynecologic Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Starting the Conversation, Sexual Health Resources.
Who it may be relevant to
Registry conditions: Gynecologic Cancers. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • Clinical Communication - Raise Topic of Sexual Health [Time frame: 2 weeks]
  • Clinical Communication - Ask a Question about Sexual Health [Time frame: 2 weeks]
  • Clinical Communication - Express a Concern about Sexual Health [Time frame: 2 weeks]
Secondary outcome measures (4)
  • Self-Reported Sexual Function [Time frame: Baseline, 2 weeks, 3 months, 6 months]
  • Self-Reported Sexual Activity [Time frame: Baseline, 2 weeks, 3 months, 6 months]
  • Self-Reported Anxiety Symptoms [Time frame: Baseline, 2 weeks, 3 months, 6 months]
  • Self-Reported Depressive Symptoms [Time frame: Baseline, 2 weeks, 3 months, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fox Chase Cancer Center — Philadelphia

Identifiers

NCT: NCT06904339 · 24-1010 · R01CA285674

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗