Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05692960 |
Other study ID # |
UTK-IRB-22-07195 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.