WISH, Feasibility of a Factorial Design

Launched by THE UNIVERSITY OF TENNESSEE, KNOXVILLE · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial, called WISH, is exploring a new way to help women who have had breast cancer and are experiencing changes in their sexual health, such as vaginal dryness, discomfort during sex, lower sexual desire, or negative feelings about their body after cancer treatment. The study aims to see if it’s possible to test a combination of treatments that could improve these issues using a specific research method called a factorial design.

Women who might join this study are those aged 18 or older who have finished their main breast cancer treatments at least three months ago but not more than ten years ago. Participants need to be able to read and write English, currently have a sexual partner, and experience vaginal dryness or pain during sex. They should also have noticed changes in their body image or sexual desire since their cancer diagnosis or treatment. Women currently on certain estrogen treatments or with active mental health conditions would not be eligible. If accepted, participants can expect to try different parts of the treatment plan to see what works best, helping researchers learn how to better support women facing these common sexual health challenges after breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 female
• • 2. Ability to read and write English
• • 3. History of any stage of breast cancer
• • 4. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
• • 5. Able to engage in sexual activity including penetration or insertion into the vagina
• • 6. Currently has a sexual partner.
• • 7. Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?"
• 8. 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:
• • 1. Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.
• • 2. An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)
• • 3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
• • 4. Previous participant in WISH Study
• • 5. Currently receiving active treatment
• • 6. Use of oral, transdermal or vaginal estrogen
• • 7. Allergy or intolerance to Replens, Hyalo Gyn or any of their components.