30 Participants Needed

OMGYES.com for Sexual Health in Female Cancer Survivors

CK
Overseen ByCassandra Kuissi, BS
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?

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'tParticipants will:* Complete online modules at home* Visit the clinic every 5 weeks for questionnaires

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.

How does the treatment OMGYES.com differ from other treatments for sexual health in female cancer survivors?

OMGYES.com is unique because it is an online platform that focuses on sexual health education and empowerment, which is different from traditional treatments like medications or physical therapies. It provides a digital, accessible approach to improving sexual health, which can be particularly beneficial for those who face geographic or logistical barriers to accessing in-person care.12345

What data supports the effectiveness of the treatment OMGYES.com for sexual health in female cancer survivors?

Educational and counseling interventions targeting sexual dysfunction have shown consistent improvement in various aspects of sexual health, which suggests that similar approaches like OMGYES.com could be beneficial for female cancer survivors.13678

Who Is on the Research Team?

AD

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.
I have been in complete remission for at least 2 months after major treatment.
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

A survey of 220 female cancer survivors revealed that common sexual health issues included pain during intercourse (87.2%), vaginal dryness (85.3%), and low libido (82.6%), with menopausal women experiencing these issues more frequently.
The majority of participants adhered to recommended therapies, such as vaginal moisturizers and lubricants (96.9-100%), and reported significant improvements in their sexual health, with 92% feeling more informed and 91% willing to recommend the program to others.
Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer.Rash, JK., Seaborne, LA., Peterson, M., et al.[2023]
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]
In a study of 155 gynecologic cancer survivors, 44.5% reported experiencing sexual dysfunction, highlighting a significant concern for this population.
Black survivors were found to be three times more likely to experience sexual dysfunction compared to white survivors, and those who underwent chemotherapy and radiation therapy had an increased risk of sexual dysfunction as well.
The association of sexual dysfunction with race in women with gynecologic malignancies.Frimer, ., Turker, LB., Shankar, V., et al.[2022]

Citations

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. [2023]
Management of sexual dysfunction in breast cancer survivors: a systematic review. [2022]
The association of sexual dysfunction with race in women with gynecologic malignancies. [2022]
Sexual health after breast cancer: Recommendations from the Spanish Menopause Society, Federación Española de Sociedades de Sexología, Sociedad Española de Médicos de Atención Primaria and Sociedad Española de Oncología Médica. [2018]
Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. [2018]
Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. [2023]
Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. [2018]
Sexual Health Screening for Gynecologic and Breast Cancer Survivors: A Review and Critical Analysis of Validated Screening Tools. [2022]
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