Psychosexual Educational Partners Program (PEPP)
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.
Conditions:
🦠 Breast Cancer 🦠 Gynecologic Cancer 🦠 Sexual Dysfunction 🦠 Partner Communication
🗓️ Study Start (Actual) 2 April 2024
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 30 September 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Knoxville, Tennessee, United States

📋 Eligibility Criteria

Description

    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 ≤ 5 years prior to registration.
    • 5. May use maintenance therapy and concurrent adjuvant endocrine therapy or human epidermal 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 intimate relationship for at least 3 months prior to her cancer diagnosis.
    • 7. Responds yes to the question "Has there been a change in communication and/or intimacy with your partner since your cancer diagnosis?"
    • 8. Both partner and woman patient must agree to participate in the study and sign informed consent to the study.
    • 9. Psychiatric medications such as antidepressants and benzodiazepines are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.

    Exclusion Criteria:

    • 1. Past history of sexual abuse.
    • 2. Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (Defined per medical history and/or patient self-report).
    • 3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 January 2024
  • First Submitted that Met QC Criteria 2 February 2024
  • First Posted 12 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024