AYA OMGYES Sexual Health Study

June 3, 2026 updated by: University of Chicago

Assessing the Impact of a Web-based Educational Program on the Sexual Health Outcomes of Young Adult Female Cancer Survivors ~ A Pilot Trial

The purpose of this study is to assess the impact of the web-based intervention OMGYES.com on sexual dysfunction in young adult (YA) female-bodied cancer survivors. This pilot trial seeks to evaluate the intervention's:

  • feasibility
  • acceptability
  • appropriateness.

Researchers will utilize an active observation period to compare outcomes between those receiving the intervention immediately and those who haven't

Participants will:

  • Complete online modules at home
  • Visit the clinic every 5 weeks for questionnaires

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Hospital
        • Principal Investigator:
          • Adam DuVall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 45 years
  • Diagnosis of cancer between the ages of 15 and 45
  • Female genitalia, regardless of gender
  • Diagnosed with sexual dysfunction
  • Complete Remission and at least two months from a major treatment
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Ability to participate in study modules and to respond to surveys
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients receiving other investigational agents
  • Patients expected to be neutropenic or have a significantly high infection risk that would exclude them from vaginal penetration
  • Patients who are unable complete the study intervention or surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Delayed Intervention
The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.
Other: OMGYES.com
OMGYES.com is an interactive website that offers information, video tutorials, interviews, tips, and resources to explore female sexual pleasure through groundbreaking research that's told through the real-life experiences of women of all ages and life stages.
Experimental: Immediate Intervention
The immediate intervention group will be administered the intervention at study enrollment.
Other: OMGYES.com
OMGYES.com is an interactive website that offers information, video tutorials, interviews, tips, and resources to explore female sexual pleasure through groundbreaking research that's told through the real-life experiences of women of all ages and life stages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)
Time Frame: End of Study (Week 6)
The Feasibility of Intervention Measure (FIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the extent at which an intervention can be successfully used in a clinical setting.
End of Study (Week 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)
Time Frame: End of Study (Week 6)
The Acceptability of Intervention Measure (AIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the extent to which participants deem an intervention agreeable, palatable, or satisfactory.
End of Study (Week 6)
Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure
Time Frame: End of Study (Week 6)
The Acceptability of Intervention Measure (AIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the perceived fit, relevance, or compatibility of an intervention for a given population; and/or perceived fit of the intervention to address a particular issue or problem
End of Study (Week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Adam DuVall, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-0909

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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