Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study

NCT05070299 | Completed

• 2 other identifiers: UMCC 2021.071HUM00202063
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Attrition rate (feasibility)

  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does not provide data both before and after completing the surveys for the study will be considered to be prematurely withdrawn and included in the attrition count.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.

  Week 6 (+2 weeks)

Secondary Outcomes (5)

• Home practice rate (acceptability)

  Week 6 (+2 weeks)

• Participant experience assessed using Thematic Analysis

  Week 6 (+2 weeks)

• Impact of intervention, measured by Dyadic Sexual Communication (DSC)

  Baseline to week 6 (+2 weeks)

• Impact of intervention, measured by PROMIS® Sexual Function and Satisfaction V2.0 (PROMIS SexF V2)

  Baseline to week 6 (+2 weeks)

• Impact of intervention, measured by Revised Dyadic Adjustment Scale (RDAS)

  Baseline to week 6 (+2 weeks)

Study Arms (1)

Psychosexual Educational Partners Program (PEPP)

EXPERIMENTAL

Women and their partners will work through a three module workbook together, completing each module over a 2-week period (6 weeks total).

Behavioral: Psychosexual Educational Partner Program (PEPP)

Interventions

Psychosexual Educational Partner Program (PEPP) BEHAVIORAL

A communication and intimacy promotion kit consisting of three modules devoted to information sharing, partner communication and activities for building intimacy.

Psychosexual Educational Partners Program (PEPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 female with a history of any stage breast and/or gynecological cancer.
• Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration.
• May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
• Responds yes to the question "Has there been change in communication and/or intimacy with your partner since your cancer diagnosis?"
• Ability to read and write English.
• 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.
• Both partner and woman must agree to participate in the study and sign informed consent to the study.

You may not qualify if:

• 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.
• Past history of sexual abuse.
• 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

• University of Michigan Rogel Cancer Center: lead
• The Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Arring 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Noel Arring, DNP, PhD, RN, OCN

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 7, 2021
• Study Start: March 15, 2022
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)