OMGYES.com for Sexual Health in Female Cancer Survivors

Overseen By Cassandra Kuissi, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Investigational agents

Disqualifiers: Neutropenia, High infection risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

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't Participants 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.

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

Research Team

Adam DuVall, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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 am between 18 and 40 years old.

I can take part in study activities and answer surveys.

I have female reproductive organs.

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

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

Treatment Details

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.

Participant Groups

Group I: Immediate Intervention Experimental Treatment 1 Intervention

The immediate intervention group will be administered the intervention at study enrollment.

Group II: Delayed Intervention Experimental Treatment 1 Intervention

The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of sexual dysfunction with race in women with gynecologic malignancies. Frimer, ., Turker, LB., Shankar, V., et al.[2022]

Breast cancer survivors often experience sexual disorders due to treatment side effects or induced menopause, highlighting the need for focused care on sexual health.

A multidisciplinary team approach is recommended to address sexual health as a vital part of treatment, aiming to enhance the quality of life for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mendoza, N., Molero, F., Criado, F., et al.[2018]

A systematic review of 171 studies on self-reported sexual function in women with a history of cancer revealed that nearly all studies indicated a decline in sexual function after cancer treatment compared to healthy controls.

The review identified 37 different measures of sexual function, with dedicated questionnaires providing more detailed assessments, suggesting that integrating these measures into patient care can enhance the understanding of quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. Jeffery, DD., Barbera, L., Andersen, BL., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. Breistig, S., Thorkildsen, KM., Werner, HMJ., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A review identified 10 validated sexual health screening tools specifically for gynecologic and breast cancer survivors, highlighting their ability to assess various aspects of sexual health, including satisfaction, desire, and dyspareunia.

While these tools are useful, they have limitations such as heterosexual bias and insufficient differentiation between lack of desire and inability, indicating a need for improvement to better address the diverse needs of cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Health Screening for Gynecologic and Breast Cancer Survivors: A Review and Critical Analysis of Validated Screening Tools. Tounkel, I., Nalubola, S., Schulz, A., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Management of sexual dysfunction in breast cancer survivors: a systematic review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The association of sexual dysfunction with race in women with gynecologic malignancies. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Sexual Health Screening for Gynecologic and Breast Cancer Survivors: A Review and Critical Analysis of Validated Screening Tools. [2022]