AYA OMGYES Sexual Health Study

The University of Chicago

Status: Enrolling

Conditions: Sexual Dysfunction

Treatments: Other: OMGYES.com

Study type: Interventional

Funder types: Other

Identifiers

NCT06868121

IRB24-0909

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Delayed Intervention

Other group

Description:

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

Treatment:

Other: OMGYES.com

Immediate Intervention

Experimental group

Description:

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

Treatment:

Other: OMGYES.com