OMGYES.com for Sexual Health in Female Cancer Survivors
Recruiting in Palo Alto (17 mi)
Overseen byAdam DuVall, MD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must not be taking: Investigational agents
Disqualifiers: Neutropenia, High infection risk, others
No Placebo Group
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.
12345How 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.
24678Eligibility 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.
+5 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Immediate InterventionExperimental Treatment1 Intervention
The immediate intervention group will be administered the intervention at study enrollment.
Group II: Delayed InterventionExperimental Treatment1 Intervention
The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago HospitalChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. [2023]Sexual health concerns are common among female cancer survivors. Few data exist regarding patient-reported outcomes following interventions in this population. We aimed to determine patient-reported adherence and impact of interventions provided in an academic specialty clinic for treatment of sexual health problems.
Management of sexual dysfunction in breast cancer survivors: a systematic review. [2022]Female sexual dysfunction occurs frequently in midlife breast cancer survivors (BCS) and encompasses problems with sexual desire, interest, arousal, orgasm and genitopelvic pain. Although common, sexual problems are under-diagnosed and under-treated in BCS. The objective of this review was to assess primary studies that intervene on sexual dysfunction in BCS. In February 2015, PubMed, SCOPUS, CINAHL, COCHRANE and Web of Science databases were systematically searched for randomized controlled clinical trials (RCTs) of vaginal (lubricants, moisturizers, estrogens, dehydroepiandrosterone [DHEA], testosterone, vibrators, dilators), systemic (androgens, anti-depressants, flibanserin, ospemifene), physical therapy (physical activity, pelvic floor training), counseling and educational interventions on sexual function in BCS. Observational studies of vaginal interventions were also included due to the paucity of RCTs. The search yielded 1414 studies, 34 of which met inclusion criteria. Both interventions and outcomes, measured by 31 different sexual function scales, were heterogeneous, and therefore data were not pooled. The review found that regular and prolonged use of vaginal moisturizers was effective in improving vaginal dryness, dyspareunia, and sexual satisfaction. Educational and counseling interventions targeting sexual dysfunction showed consistent improvement in various aspects of sexual health. No consistent improvements in sexual health were observed with physical activity, transdermal testosterone or hot flash interventions. There was a lack of BCS-specific data on vaginal lubricants, vibrators, dilators, pelvic floor therapy, flibanserin or ospemifene. Overall, the quality of evidence for these studies was moderate to very low. Because each of the interventions with BCS data had limited efficacy, clinical trials to test novel interventions are needed to provide evidence-based clinical recommendations and improve sexual function in BCS.
The association of sexual dysfunction with race in women with gynecologic malignancies. [2022]Gynecologic cancer survivors report sexual health among their highest concerns. The aim of this study was to identify the prevalence of sexual dysfunction (SD) in survivors of gynecologic malignancies and to evaluate the association of sexual function with race, ethnicity and treatment modality. In this study, survivors of endometrial, cervical, vaginal, and vulvar cancer who presented to the gynecologic oncology practice were asked to self-administer the Female Sexual Function Index (FSFI) survey to evaluate their sexual function. The prevalence of SD was estimated and its association with demographic and clinical co-variates was analyzed. Of the 155 participants, the prevalence of SD was 44.5% (95%CI: 36.7-52.7). Patients were significantly more likely to report SD if they did not currently have a partner (69% vs 22% p < .01). Abstinence within six months of their cancer diagnosis was also associated with SD (72% vs 26% p < .01). Patients who self-identified as black race compared to white race were three times more likely to have SD (OR = 3.9, 95% CI 1.1-14.3). Patients who received adjuvant chemotherapy and radiation therapy compared to those who did not among the entire cohort had an increased risk of SD (OR = 3.4, 95% CI 1.2-9.6). In our diverse population, almost half of our patients were identified to have SD. Black as compared to white race reported significantly higher sexual dysfunction. An increased risk for sexual dysfunction was observed among those women who received chemotherapy and radiation with or without surgery.
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]Breast cancer is the most common cancer in women. As survival rates are increasing, the long-term health problems of survivors now need attention. Many survivors develop sexual disorders as a consequence of either the side-effects of treatment or induced menopause. A panel of experts from various Spanish scientific societies (Spanish Menopause Society, SMS; Federación Española de Sociedades de Sexología, FESS; Sociedad Española de Médicos de Atención Primaria, SEMERGEN; and Sociedad Española de Oncología Médica) met to develop recommendations for the management of sexual health in breast cancer survivors based on the best evidence available. The main recommendation is that sexuality must be considered by a multidisciplinary team as an integral part of treatment, to improve the quality of life of breast cancer survivors.
Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. [2018]A systematic review was conducted to identify and characterize self-reported sexual function (SF) measures administered to women with a history of cancer. Using 2009 PRISMA guidelines, we searched electronic bibliographic databases for quantitative studies published January 2008-September 2014 that used a self-reported measure of SF, or a quality of life (QOL) measure that contained at least 1 item pertaining to SF. Of 1,487 articles initially identified, 171 were retained. The studies originated in 36 different countries with 23% from US-based authors. Most studies focused on women treated for breast, gynecologic, or colorectal cancer. About 70% of the articles examined SF as the primary focus; the remaining examined QOL, menopausal symptoms, or compared treatment modalities. We identified 37 measures that assessed at least one domain of SF, eight of which were dedicated SF measures developed with cancer patients. Almost one third of the studies used EORTC QLQ modules to assess SF, and another third used the Female Sexual Function Inventory. There were few commonalities among studies, though nearly all demonstrated worse SF after cancer treatment or compared to healthy controls. QOL measures are better suited to screening while dedicated SF questionnaires provide data for more in depth assessment. This systematic review will assist oncology clinicians and researchers in their selection of measures of SF and encourage integration of this quality of life domain in patient care.
Redefining sexual health after gynaecological cancer: Lived experiences from Gynea, a digital rehabilitation programme. [2023]Gynaecological cancer illness and treatment have a significant impact on women's sexual health and concerns regarding sexual health are known to be an unmet need in survivors. The digital support programme Gynea was designed to enhance women's health, including sexual health, after gynaecological cancer treatment. This study aimed to explore how cancer survivors experienced participation in Gynea.
Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. [2018]Sexual health is an integral component of quality of life for cancer survivors, and is often negatively impacted by treatment. Geographic limitations often prohibit survivors from accessing sexual health programs designed to address their needs. This study examined the efficacy of an online, 12-week psychoeducational program, which included elements of mindfulness meditation, for sexual difficulties in survivors of colorectal or gynecologic cancer. Complete pre- and postintervention data were available for 46 women (mean age 55.0, SD 9.6) and 15 men (mean age 59.7, SD 6.8). Women experienced significant improvements in sex-related distress (p
Sexual Health Screening for Gynecologic and Breast Cancer Survivors: A Review and Critical Analysis of Validated Screening Tools. [2022]Studies have shown that the sexual health concerns of gynecologic and breast cancer survivors are not adequately being addressed by clinicians.