Sexual Dysfunction, PhysiologicalWISHNCT05692960
Women's Interventions for Sexual Health: WISH
A study testing Hypnotic Relaxation Intervention (HRI) and Vulvovaginal Atrophy (VVA) in people with Sexual Dysfunction, Physiological and Body Image, run by The University of Tennessee, Knoxville at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Sexual Dysfunction, Physiological, Body Image, Libido; Loss, Aversion
- What is being tested?
- Hypnotic Relaxation Intervention (HRI) and Vulvovaginal Atrophy (VVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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?"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Women's Interventions for Sexual Health: WISH, A Pilot Study
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.
Read the 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.
- Being tested
- Hypnotic Relaxation Intervention (HRI), Vulvovaginal Atrophy (VVA)
- Keywords
- breast cancer, vulvovaginal atrophy, libido, body image
- Medical subject headings
- Sexual Dysfunction, Physiological, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Relaxation Intervention (HRI)Other
HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)
Vulvovaginal Atrophy (VVA)Device
VVA is a standard of care intervention (Replens™ vaginal moisturizer device)
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic Relaxation Intervention (HRI) | Experimental | 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. Receives: Other: Hypnotic Relaxation Intervention (HRI) |
| Vulvovaginal Atrophy (VVA) | Other | 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. Receives: Device: Vulvovaginal Atrophy (VVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen Failure Rate (a Measure of Feasibility)
The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Measured: Up to 30 days Recruitment to screening
Accrual Rate (a Measure of Feasibility)
The number of participants who consented divided by the number eligible
Measured: 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.
Measured: Baseline through study completion, 8 weeks
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: consent to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Feb 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunction, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Noel M Arring, DNP, PhD, RN, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692960
- Sponsor's protocol ID
- UTK-IRB-22-07195
- Acronym
- WISH
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2022
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
Arring NM, Lafferty C, Carter J, Marshall D, Reese JB. A pilot randomized controlled trial of a multicomponent intervention to improve sexual function in female breast cancer survivors. Front Oncol. 2026 Sep 9;16:1895188. doi: 10.3389/fonc.2026.1895188. eCollection 2026.
PubMed 42780192
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Interventions for Sexual Health: WISH, A Pilot Study
- ClinicalTrials.gov ID
- NCT05692960
- Acronym / sponsor ID
- WISH / UTK-IRB-22-07195
- Keywords
- breast cancer, vulvovaginal atrophy, libido, body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hypnotic Relaxation Intervention (HRI) | Experimental | Other: Hypnotic Relaxation Intervention (HRI)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. |
| Vulvovaginal Atrophy (VVA) | Other | Device: Vulvovaginal Atrophy (VVA)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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Relaxation Intervention (HRI)HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention) | Other | Hypnotic Relaxation Intervention (HRI) |
| Vulvovaginal Atrophy (VVA)VVA is a standard of care intervention (Replens™ vaginal moisturizer device) | Device | Vulvovaginal Atrophy (VVA) |
Primary outcome
Screen Failure Rate (a Measure of Feasibility)
Time frame: Up to 30 days Recruitment to screening
The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Accrual Rate (a Measure of Feasibility)
Time frame: Up to 30 days Screening to consent
The number of participants who consented divided by the number eligible
Retention Rate/Acceptability (a Measure of Feasibility)
Time frame: Baseline through study completion, 8 weeks
The number of participants who completed the 8 weeks of the study divided by the number who consented.
3 secondary outcomes
Female Sexual Function Index (FSFI)
Time frame: consent to week 8
Breast Impact of Treatment Scale (BITS)
Time frame: consent to week 8
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
Time frame: consent to week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42780192Arring NM, Lafferty C, Carter J, Marshall D, Reese JB. A pilot randomized controlled trial of a multicomponent intervention to improve sexual function in female breast cancer survivors. Front Oncol. 2026 Sep 9;16:1895188. doi: 10.3389/fonc.2026.1895188. eCollection 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel M Arring, DNP, PhD, RN principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Relaxation Intervention (HRI) and Vulvovaginal Atrophy (VVA) in people with Sexual Dysfunction, Physiological and Body Image, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen Failure Rate (a Measure of Feasibility) (time frame: Up to 30 days Recruitment to screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.