Women's Interventions for Sexual Health: WISH

Body Image Clinical Trial

— WISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05692960
• Other study ID #: UTK-IRB-22-07195
• Status: Completed
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: February 9, 2024

Study information

• Verified date: May 2024
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• History of breast cancer, stages I, II or III

• Completed primary treatment (chemotherapy, radiation and/or surgery) =3 months and = 5 years prior to registration

• May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study

• May use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sex

• Ability to read and write English

• Able to engage in sexual activity

• Currently 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:

1. "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or

2. "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 change

• History of sexual abuse

• Psychiatric 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

Related Conditions & MeSH terms

• Body Image
• Sexual Dysfunction, Physiological

Intervention

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)

Locations

Country	Name	City	State
United States	University of Tennessee Knoxville	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screen failure rate (a measure of feasibility)	The number of women screened ineligible	Up to 30 days Recruitment to screening
Primary	Accrual rate (a measure of feasibility)	The number of participants who consented divided by the number eligible	Up to 30 days Screening to consent
Primary	Retention rate/Acceptability (a measure of feasibility)	The number of participants who complete the 8 weeks of the study divided by the number who consented.	Baseline through study completion, 8 weeks
Secondary	Female Sexual Function Index (FSFI)	Change in FSFI score	consent to week 8
Secondary	Breast- Impact of Treatment Scale (BITS)	Change in ITS score	consent to week 8
Secondary	Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction	Change in PROMIS sexual function score	consent to week 8