Clinical trial · Interventional
Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study
NCT05070299CI-TRIAL-00063876completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm study to evaluate the feasibility, adherence, and usefulness of a psychosexual education partner program (PEPP) to improve partner communication and sexual function. This study is intended to get initial input from a small group of up to 10 women and their partners about the appropriateness, usefulness, and critical nature of the content as well as the feasibility and appeal of the method of delivery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosexual Educational Partner Program (PEPP) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Psychosexual Educational Partners Program (PEPP)
- description
- Women and their partners will work through a three module workbook together, completing each module over a 2-week period (6 weeks total).
- interventionNames
- Behavioral: Psychosexual Educational Partner Program (PEPP)
Primary outcomes (1)
- measure
- Attrition rate (feasibility)
- timeFrame
- Week 6 (+2 weeks)
- description
- After completion of each module the interventionist will contact patients and their partners by phone and document completion of the module's exercise. Anyone who does not provide data both before and after completing the surveys for the study will be considered to be prematurely withdrawn and included in the attrition count. The intervention will be considered feasible if the attrition rate is 25% or less at week 6 (+2 weeks). Withdrawal reasons will be captured and reported by category.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria below apply only to the patient. (The patient's partner must be 18 years of age or older.) Patient Inclusion Criteria: 1. Age ≥18 female with a history of any stage breast and/or gynecological cancer. 2. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration. 3. May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study. 4. Responds yes to the question "Has there been change in communication and/or intimacy with your partner since your cancer diagnosis?" 5. Ability to read and write English. 6. A stable partner, defined as anyone with whom the woman has had an intimate relationship with for at least 3 months prior to her cancer diagnosis. 7. Both partner and woman must agree to participate in the study and sign informed consent to the study. Patient Exclusion Criteria: 1. 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. 2. Past history of sexual abuse. 3. Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.) 4. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
References
Publications (1)
- DERIVEDArring NM, Reese JB, Lafferty C, Barton DL, Carter J. A Sexual Health Self-Management Intervention (Psychosexual Educational Partners Program) for Couples With a History of Breast and Gynecological Cancer: Mixed Methods Feasibility Study. JMIR Form Res. 2025 Oct 21;9:e75743. doi: 10.2196/75743. PMID 41118642