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Women's Interventions for Sexual Health: WISH (WISH)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnotic Relaxation Intervention (HRI)
Vulvovaginal Atrophy (VVA)
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sexual Dysfunction, Physiological focused on measuring breast cancer, vulvovaginal atrophy, libido, body image

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: "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: 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

Sites / Locations

  • University of Tennessee KnoxvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypnotic Relaxation Intervention (HRI)

Vulvovaginal Atrophy (VVA)

Arm Description

The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.

This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.

Outcomes

Primary Outcome Measures

Screen failure rate (a measure of feasibility)
The number of women screened ineligible
Accrual rate (a measure of feasibility)
The number of participants who consented divided by the number eligible
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.

Secondary Outcome Measures

Female Sexual Function Index (FSFI)
Change in FSFI score
Breast- Impact of Treatment Scale (BITS)
Change in ITS score
Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction
Change in PROMIS sexual function score

Full Information

First Posted
December 14, 2022
Last Updated
August 10, 2023
Sponsor
The University of Tennessee, Knoxville
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05692960
Brief Title
Women's Interventions for Sexual Health: WISH
Acronym
WISH
Official Title
Women's Interventions for Sexual Health: WISH, A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
Collaborators
Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological, Body Image, Libido; Loss, Aversion
Keywords
breast cancer, vulvovaginal atrophy, libido, body image

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm, randomized clinical trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnotic Relaxation Intervention (HRI)
Arm Type
Experimental
Arm Description
The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.
Arm Title
Vulvovaginal Atrophy (VVA)
Arm Type
Other
Arm Description
This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.
Intervention Type
Other
Intervention Name(s)
Hypnotic Relaxation Intervention (HRI)
Intervention Description
HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)
Intervention Type
Device
Intervention Name(s)
Vulvovaginal Atrophy (VVA)
Intervention Description
VVA is a standard of care intervention (Replens™ vaginal moisturizer device)
Primary Outcome Measure Information:
Title
Screen failure rate (a measure of feasibility)
Description
The number of women screened ineligible
Time Frame
Up to 30 days Recruitment to screening
Title
Accrual rate (a measure of feasibility)
Description
The number of participants who consented divided by the number eligible
Time Frame
Up to 30 days Screening to consent
Title
Retention rate/Acceptability (a measure of feasibility)
Description
The number of participants who complete the 8 weeks of the study divided by the number who consented.
Time Frame
Baseline through study completion, 8 weeks
Secondary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI)
Description
Change in FSFI score
Time Frame
consent to week 8
Title
Breast- Impact of Treatment Scale (BITS)
Description
Change in ITS score
Time Frame
consent to week 8
Title
Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction
Description
Change in PROMIS sexual function score
Time Frame
consent to week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: "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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie K Lafferty, PhD
Phone
865-974-9463
Email
claffer2@utk.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Noel M Arring, DNP,PhD,RN
Phone
865-974-1988
Email
narring@utk.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L Barton, PhD,RN,FAAN
Organizational Affiliation
University of Tennessee Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie K Lafferty, PhD
Phone
865-974-0500
Email
claffer2@utk.edu
First Name & Middle Initial & Last Name & Degree
Noel M Arring, DNP,PhD,RN
Phone
865-974-1988
Email
narring@utk.edu
First Name & Middle Initial & Last Name & Degree
Debra L Barton, PhD,RN,FAAN
First Name & Middle Initial & Last Name & Degree
Noel M Arring, DNP,PhD,RN

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data sharing requests for deidentified data as appropriate.

Learn more about this trial

Women's Interventions for Sexual Health: WISH

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