CompletedNot Applicable

WISH, Feasibility of a Factorial Design

United States18 participantsStarted 2025-06-16

Plain-language summary

The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 female
. Ability to read and write English
. History of any stage of breast cancer
. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
. Able to engage in sexual activity including penetration or insertion into the vagina
. Currently has a sexual partner.
. Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?"
. Responds "yes" to at least one of the following questions:

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.
. An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accrual Rate

Timeframe: Screening to consent, up to 30 days.

Retention Rate

Timeframe: Consent through study completion, an average of 8 weeks.

Adherence Rate, Moisturizer

Timeframe: Consent through study completion, an average of 8 weeks.

Adherence Rate, Relaxation Intervention

Timeframe: Consent through study completion, an average of 8 weeks.

Trial details

NCT IDNCT07023822

SponsorThe University of Tennessee, Knoxville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-03

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 female
. Ability to read and write English
. History of any stage of breast cancer
. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
. Able to engage in sexual activity including penetration or insertion into the vagina
. Currently has a sexual partner.
. Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?"
. Responds "yes" to at least one of the following questions:

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.
. An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)

What they're measuring

Accrual Rate

Timeframe: Screening to consent, up to 30 days.

Retention Rate

Timeframe: Consent through study completion, an average of 8 weeks.

Adherence Rate, Moisturizer

Timeframe: Consent through study completion, an average of 8 weeks.

Adherence Rate, Relaxation Intervention

Timeframe: Consent through study completion, an average of 8 weeks.