AYA OMGYES Sexual Health Study

Not Applicable

Recruiting

• Conditions: Sexual Dysfunction

• Registration Number: NCT06868121
• Lead Sponsor: University of Chicago

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-16
• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Age 18 to 40 years
• Diagnosis of cancer between the ages of 15 and 40
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)	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.
Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure	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

Trial Locations

Locations (1)

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States