AYA OMGYES Sexual Health Study

NCT06868121 | Recruiting DMC

• 1 other identifier: IRB24-0909
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)

  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 Outcomes (2)

• Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)

  End of Study (Week 6)

• Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure

  End of Study (Week 6)

Study Arms (2)

Delayed Intervention

OTHER

The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.

Other: OMGYES.com

Immediate Intervention

EXPERIMENTAL

The immediate intervention group will be administered the intervention at study enrollment.

Other: OMGYES.com

Interventions

OMGYES.com OTHER

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.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Adam DuVall, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Kuissi, BS

CONTACT

7737021220; cassandra.kuissi@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 10, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-05

Locations

US (1)