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Recruiting NCT05692960

Women's Interventions for Sexual Health: WISH

Conditions: Sexual Dysfunction, Physiological, Body Image, Libido; Loss, Aversion

Sex: Female
Ages: 18 Years – 99 Years
Phase: NA
Enrollment: 30
Sponsor: The University of Tennessee, Knoxville

Location: United States

Summary

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vulvovaginal tissue quality and symptoms, desire/energy, and relationship-partner concerns. This proposal begins the proof-of-concept pilot study in women with a history of breast cancer to deliver a multi-component intervention to improve vulvo-vaginal atrophy with a vaginal moisturizer, and sexual energy and self-image with a mind-body intervention that involves relaxation and subconscious suggestions with a hypnotic induction delivered via audio file. The primary outcome will be to evaluate the feasibility and acceptability of a multi-component intervention for sexual function. It is hypothesized that at least eighty percent of randomized participants will complete the study without differential withdraws from the control group.

Eligibility Criteria

Inclusion Criteria:History of breast cancer, stages I, II or IIICompleted primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 5 years prior to registrationMay use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on studyMay use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sexAbility to read and write EnglishAble to engage in sexual activityCurrently has a sexual partner Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or pain with sexual activity?"Responds "yes" to at least one of the following questions:"Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or"Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"Exclusion Criteria:Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to changeHistory of sexual abusePsychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report)Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)Use of oral, transdermal or vaginal estrogen is not allowed while on study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05692960). StuddyBuddy aggregates publicly available trial information.