Assessing the Impact of a Web-based Educational Program on the Sexual Health Outcomes of Young Adult Female Cancer Survivors ~ A Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Chicago
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Delayed Intervention
The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.
Intervention: OMGYES.com (Other)
Immediate Intervention
The immediate intervention group will be administered the intervention at study enrollment.
Intervention: OMGYES.com (Other)
Outcomes
Primary Outcomes
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)
Time Frame: 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 Outcomes
- Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)(End of Study (Week 6))
- Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure(End of Study (Week 6))