30 Participants Needed

OMGYES.com for Sexual Health in Female Cancer Survivors

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Overseen ByAdam DuVall, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a web-based program, OMGYES.com, can improve sexual health in young adult women who have survived cancer. The study evaluates the program's ease of use and effectiveness by comparing women who start using it immediately with those who wait a few weeks. Women in remission from cancer who have experienced sexual dysfunction may be suitable for this trial. Participants will complete online modules at home and visit a clinic every 5 weeks to answer questions. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sexual health resources for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this web-based intervention is safe for female cancer survivors?

Research has shown that OMGYES.com, an online program, is generally safe and well-received. Previous studies examined its ease of use and acceptability, without identifying any major side effects. The program helps women learn more about their sexual health, and no negative effects have been reported from its use.

Due to the absence of specific safety data, the study's phase is classified as "Not Applicable." This classification typically indicates that the program is non-invasive and low-risk, focusing on educational content rather than medicine or surgery.

Overall, OMGYES.com appears to be a safe choice for female cancer survivors seeking to improve their sexual health.12345

Why are researchers excited about this trial?

Researchers are excited about OMGYES.com for sexual health in female cancer survivors because it offers a novel, interactive approach to improving sexual well-being. Unlike traditional treatments that may focus on medication or therapy sessions, OMGYES.com provides an online platform that educates users through videos and tactile learning. This method empowers women to explore and understand their bodies in a private, comfortable setting, potentially leading to improved sexual satisfaction and quality of life.

What evidence suggests that OMGYES.com might be an effective treatment for sexual dysfunction?

Research has shown that OMGYES.com, an online educational resource, may enhance women's sexual health. Studies have found that women using OMGYES.com gain a better understanding of their own sexual pleasure and develop more positive feelings about it. This is particularly important for female cancer survivors, who often face sexual health issues. In this trial, participants will be divided into two groups: the immediate intervention group, which will use OMGYES.com at study enrollment, and the delayed intervention group, which will begin using it after a 5-week observation period. Early results suggest that this online tool is not only easy to use and well-received but could also effectively boost sexual well-being. These benefits make OMGYES.com a promising option for those seeking to improve their sexual health after cancer treatment.12345

Who Is on the Research Team?

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Adam DuVall, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for young adult female-bodied cancer survivors experiencing sexual dysfunction. Participants will engage with an online platform from home and visit the clinic every 5 weeks to complete questionnaires.

Inclusion Criteria

I can take part in study activities and answer surveys.
I have female reproductive organs.
Ability to understand and the willingness to sign a written informed consent document
See 4 more

Exclusion Criteria

Patients who are unable complete the study intervention or surveys
Patients receiving other investigational agents
I am at high risk for infections and cannot have vaginal penetration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Observation

Delayed intervention group undergoes 5 weeks of active observation prior to intervention administration

5 weeks
1 visit (in-person) every 5 weeks for questionnaires

Intervention

Immediate intervention group receives the web-based intervention OMGYES.com at study enrollment

6 weeks
1 visit (in-person) every 5 weeks for questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • OMGYES.com
Trial Overview The study is testing the impact of a web-based intervention, OMGYES.com, on improving sexual health. It compares outcomes between those who start using the site immediately and those who do not yet have access.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Immediate InterventionExperimental Treatment1 Intervention
Group II: Delayed InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

Regular and prolonged use of vaginal moisturizers significantly improves vaginal dryness, dyspareunia (pain during intercourse), and overall sexual satisfaction in midlife breast cancer survivors, based on a review of 34 studies.
Educational and counseling interventions consistently enhance various aspects of sexual health in breast cancer survivors, highlighting the importance of addressing sexual dysfunction, although the overall quality of evidence remains moderate to very low.
Management of sexual dysfunction in breast cancer survivors: a systematic review.Seav, SM., Dominick, SA., Stepanyuk, B., et al.[2022]
A 12-week online psychoeducational program significantly improved sexual function, sex-related distress, and mood in women cancer survivors, with benefits lasting up to six months after the program ended.
While men showed some improvement in intercourse satisfaction, their overall sexual desire did not significantly change, indicating a need for more tailored interventions for male survivors.
Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors.Brotto, LA., Dunkley, CR., Breckon, E., et al.[2018]
The Gynea digital support program significantly helped 20 women cancer survivors redefine their sexual health, emphasizing empowerment and communication with partners rather than just sexual function.
Participation in Gynea enhanced women's understanding of their sexual needs, which was crucial for regaining intimacy and sexual integrity in their relationships after gynaecological cancer treatment.
Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme.Breistig, S., Thorkildsen, KM., Werner, HMJ., et al.[2023]

Citations

OMGYES.com for Sexual Health in Female Cancer SurvivorsTrial Overview The study is testing the impact of a web-based intervention, OMGYES.com, on improving sexual health. It compares outcomes between those who start ...
“OMG, Yes!”: Feasibility, Acceptability, and Preliminary ...The purpose of this study was to evaluate the acceptability, feasibility, and preliminary efficacy of using an online educational resource that presents ...
“OMG, Yes!”: Feasibility, Acceptability, and Preliminary ...The purpose of this study was to evaluate the acceptability, feasibility, and preliminary efficacy of using an.
Sexual Health as a Survivorship Issue for Female Cancer ...Women treated for cancer often experience issues related to sexual health and intimacy. The authors reviewed a contemporary understanding of sexual health ...
(PDF) “OMG, Yes!”: Feasibility, Acceptability, and ...Our data suggest that OMGyes.com may be useful for positively impacting how women think about sexual pleasure, how they understand their own ...
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