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.

Age range18 Years – 99 Years

SexFEMALE

See this in plain English?

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

✓. 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:

✕. 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)
✕. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
✕. Previous participant in WISH Study
✕. Currently receiving active treatment
✕. Use of oral, transdermal or vaginal estrogen
✕. Allergy or intolerance to Replens, Hyalo Gyn or any of their components.

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.

NCT IDNCT07023822

SponsorThe University of Tennessee, Knoxville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-03

Who can participate

Age range18 Years – 99 Years

SexFEMALE

See this in plain English?

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

✓. 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:

✕. 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)
✕. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
✕. Previous participant in WISH Study
✕. Currently receiving active treatment
✕. Use of oral, transdermal or vaginal estrogen
✕. Allergy or intolerance to Replens, Hyalo Gyn or any of their components.

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.