AYA OMGYES Sexual Health Study
ConditionSexual Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Chicago
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 45 years
Diagnosis of cancer between the ages of 15 and 45
Female genitalia, regardless of gender
Diagnosed with sexual dysfunction
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
OMGYES.com
Other interventionOMGYES.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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Delayed InterventionOther 1 intervention
Group B: Immediate InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
End of Study (Week 6)Secondary outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov