Psychosexual Educational Partners Program (PEPP)

NCT06253182 | Active Not Recruiting

• 1 other identifier: UTK IRB-23-07925-XP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Gynecologic Cancer; Sexual Dysfunction; Partner Communication

Keywords

breast cancer; gynecologic cancer; sexual dysfunction; partner communication; couples; intimacy; sexual health

Outcome Measures

Primary Outcomes (1)

• Dyadic Sexual Communication (DSC)

  The preliminary efficacy of the revised PEPP intervention on sexual communication among dyads. The DSC is a single-dimensional 13-item scale that measures sexual communication between partners on a 4-point Likert scale, disagree strongly to agree strongly. Possible scores range from 13-52 with higher scores indicating better sexual communication.

  consent through study completion, an average of 8 weeks

Secondary Outcomes (3)

• Self-Efficacy to Communicate about Sex and Intimacy (SECSI)

  consent through study completion, an average of 8 weeks

• Adherence rate

  consent of first participant through study completion of last participant, up to 1 year

• Adverse events

  consent through study completion, an average of 8 weeks

Study Arms (2)

Self-Guided PEPP Intervention workbook

EXPERIMENTAL

Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns.

Behavioral: Self-Guided PEPP Intervention Workbook

Self-Guided PEPP Education Workbook

ACTIVE COMPARATOR

Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns.

Behavioral: Self-Guided PEPP Education Workbook

Interventions

Self-Guided PEPP Intervention Workbook BEHAVIORAL

The workbook contains 3 modules. To complete the workbook in six weeks (one module every 2 weeks), it is recommended that a dyad schedule at least three 30-minute blocks of time each week. Dyads are asked to work through the modules in order and encouraged to set a pace that works for them.

Self-Guided PEPP Intervention workbook

Self-Guided PEPP Education Workbook BEHAVIORAL

The workbook contains 3 modules. To complete the workbook in six weeks (one module every 2 weeks), it is recommended that a dyad schedule at least three 30-minute blocks of time each week. Dyads are asked to work through the modules in order and encouraged to set a pace that works for them.

Self-Guided PEPP Education Workbook

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Eligible participants must be female breast or gynecological cancer survivors and their intimate partners.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 female.
• Able to read and write in English.
• History of any stage of breast and/or gynecological cancer.
• Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 10 years prior to registration.
• May use maintenance therapy and concurrent adjuvant endocrine therapy or human epidermal growth factor receptor 2 negative (HER2-) targeted therapy while on study.
• 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.
• Responds yes to the question "Has there been a change in communication and/or intimacy with your partner since your cancer diagnosis?"
• Both partner and woman patient must agree to participate in the study and sign informed consent to the study.
• 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.

You may not qualify if:

• Past history of sexual abuse.
• Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (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).

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of Tennessee Knoxville

Knoxville, Tennessee, 37916, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Noel M Arring, DNP, PhD, RN

  University of Tennessee Knoxville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single masking, participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm randomized controlled trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: April 2, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)