Psychosexual Educational Partners Program (PEPP)

Last updated: March 14, 2025
Sponsor: The University of Tennessee, Knoxville
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sexual Dysfunction

Impotence

Erectile Dysfunction

Treatment

Self-Guided PEPP Intervention Workbook

Self-Guided PEPP Education Workbook

Clinical Study ID

NCT06253182
UTK IRB-23-07925-XP
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT).

The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 female.

  2. Able to read and write in English.

  3. History of any stage of breast and/or gynecological cancer.

  4. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 10 years prior to registration.

  5. May use maintenance therapy and concurrent adjuvant endocrine therapy or humanepidermal growth factor receptor 2 negative (HER2-) targeted therapy while on study.

  6. Have a stable partner, defined as anyone with whom the woman has had an intimaterelationship for at least 3 months prior to her cancer diagnosis.

  7. Responds yes to the question "Has there been a change in communication and/orintimacy with your partner since your cancer diagnosis?"

  8. Both partner and woman patient must agree to participate in the study and signinformed consent to the study.

  9. Psychiatric medications such as antidepressants and benzodiazepines are allowed if aperson has been on them for 30 days prior to registration, and dose or treatment isnot expected to change.

Exclusion

Exclusion Criteria:

  1. Past history of sexual abuse.

  2. Uncontrolled psychiatric disorder such as major depressive disorder, bipolardisorder, obsessive compulsive disorder, or schizophrenia (Defined per medicalhistory and/or patient self-report).

  3. Currently enrolled in another study that addresses sexual health (enrollment inother clinical trials will be allowed).

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Self-Guided PEPP Intervention Workbook
Phase:
Study Start date:
April 02, 2024
Estimated Completion Date:
April 30, 2025

Study Description

The Psychosexual Educational Partners Program (PEPP) is a two-arm pilot randomized controlled trial that will compare two approaches to a self-paced, workbook-based intervention. PEPP was designed to enhance intimacy among breast and gynecological cancer survivors and their partners by improving sexual communication. The primary aim of the study is to assess the preliminary efficacy of the revised PEPP intervention on sexual communication. Secondary aims include assessing the preliminary efficacy of PEPP on self-efficacy to communicate about sex and intimacy among cancer survivors; and evaluating adherence, acceptance and adverse events within each study arm.

The intervention is six weeks long and does not require any in-person visits. If a breast or gynecological cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, participants will be emailed the consent form and will schedule a virtual consent/baseline visit that will include their partner. After consent is obtained from both partners, the dyad will be randomly assigned to a study arm and given study numbers. Both members of the dyad will complete online surveys at the virtual baseline visit. The PEPP workbook will be sent to the participants' address and a virtual education visit will be scheduled. At this second virtual visit, both members of the dyad will receive education about their study arm and a start date will be agreed upon for week 1. Beginning week 1 and continuing through week 6, dyads will work through the PEPP workbook which contains three modules. Participants will receive a scheduled email and/or text check-in message from study staff every two weeks to coincide with the end of each module. Messages will provide a link to a brief survey to assess adherence and respond to any participant questions or concerns. Online surveys will be repeated and adverse events will be assessed at week 6.

Connect with a study center

  • University of Tennessee Knoxville

    Knoxville, Tennessee 37916
    United States

    Site Not Available

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