Sexual Dysfunction
Conditions
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
Interventions
OTHEROMGYES.com
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTCassandra Kuissi, BS
PRINCIPAL_INVESTIGATORAdam DuVall, MD
University of Chicago
Outcome results
None listed