AYA OMGYES Sexual Health Study

University of Chicago30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sexual Dysfunction

Interventions

OMGYES.comOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago Hospital

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: End of Study (Week 6)

Secondary Outcomes

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

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.

Time frame: End of Study (Week 6)

Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure

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

Time frame: End of Study (Week 6)

Central Contacts

Cassandra Kuissi, BS

CONTACT

7737021220 cassandra.kuissi@bsd.uchicago.edu

Data from ClinicalTrials.gov

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