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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)
VVA is a standard of care intervention (Replens™ vaginal moisturizer device)
University of Tennessee Knoxville
Knoxville, Tennessee, United States
Screen Failure Rate (a Measure of Feasibility)
The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Time frame: Up to 30 days Recruitment to screening
Accrual Rate (a Measure of Feasibility)
The number of participants who consented divided by the number eligible
Time frame: Up to 30 days Screening to consent
Retention Rate/Acceptability (a Measure of Feasibility)
The number of participants who completed the 8 weeks of the study divided by the number who consented.
Time frame: Baseline through study completion, 8 weeks
Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a 19-item scale that measures the following domains of female sexual functioning: desire (subscale scale = 1.2-6), arousal (subscale = 0-6), satisfaction (subscale = 0.8-6), orgasm (subscale = 0-6), lubrication (subscale = 0-6) and pain (subscale = 0-6). When the scores of these domains are added together, the sum represents an FSFI total score. The following subscales were examined in this study: FSFI total (subscale range = 2-36 where higher scores indicate better sexual function); lubrication (subscale = 0-6 where higher scores indicate greater lubrication), pain (subscale = 0-6 where lower scores indicate greater pain); and desire (subscale scale = 1.2-6 where higher scores indicate greater desire).
Time frame: consent to week 8
Breast Impact of Treatment Scale (BITS)
The Breast Impact of Treatment Scale (BITS) is a 13-item scale that measures body change stress in women with breast cancer. Scores range from 0-65. Higher scores indicate greater body change stress.
Time frame: consent to week 8
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
The PROMIS SexF V2 is a 14-item scale that includes screener items and measures sexual activities, symptoms, functioning, and evaluation of sexual experiences. It includes the following domains: interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, orgasm and pleasure, and satisfaction. Raw scores were converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described. Researchers are encouraged to select the sexual function and satisfaction domains and items that are relevant to the specific sample being studied. In this study, the interest, satisfaction and lubrication subscales were used.
Time frame: consent to week 8
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