NCT05692960

Women's Interventions for Sexual Health: WISH

Women's Interventions for Sexual Health: WISH, A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Women's Interventions for Sexual Health (WISH), is a two-arm randomized clinical trial to evaluate the feasibility and acceptability of a multi-component intervention addressing changes in body image, sexual desire, and vaginal dryness in thirty adult post-treatment breast cancer survivors. The study is eight weeks long and does not require any in-person visits. If a breast cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, they will be emailed the consent form and will schedule a virtual consent/baseline visit. After consent is obtained, the participant will be randomly assigned to a study arm, HRI (hypnotic relaxation intervention plus vaginal moisturizer) or VVA (vulvovaginal atrophy moisturizer only), given a study number, and educated on the use of Replens™ vaginal moisturizer. The participant will complete online surveys at the virtual baseline visit. Replens™ vaginal moisturizer will be sent to the participant's address and receipt of the moisturizer will be confirmed by study staff before the agreed upon week one start date. The participant will use the moisturizer every day during weeks one and two and every other day during weeks three through eight. Participants randomized to the HRI group will also receive an MP3 player with three hypnotic relaxation audio files and asked to complete a weekly practice log. Each hypnotic induction audio file will be used for two weeks, three times per week, for a total of six weeks of hypnosis. A second virtual visit will be held at two weeks to assess progress, adverse events and provide education to the HRI group. Check in phone calls will be scheduled for weeks four, six and eight. A link to online follow up surveys will be shared during weeks six and eight.

Conditions

• Sexual Dysfunction, Physiological
• Body Image
• Libido; Loss, Aversion

Interventions

Type	Name	Description
OTHER	Hypnotic Relaxation Intervention (HRI)	HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)
DEVICE	Vulvovaginal Atrophy (VVA)	VVA is a standard of care intervention (Replens™ vaginal moisturizer device)

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-02-09
• Completion: 2024-02-09
• First posted: 2023-01-20
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study