Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study

NCT ID: NCT05070299

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-08-29

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.

Detailed Description

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast or gynecologic cancer. The investigators are developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vaginal symptoms, desire/energy, and relationship-partner concerns. This proposal addresses the evaluation of this last component, relationship-partner concerns. The planned intervention to address these concerns is a psychosexual education partner program (PEPP) delivered by workbook and three follow up phone calls (to coincide with the end of each module) to women and their partners who have experienced a negative change in their relationship since their cancer diagnosis. Ten women with breast or gynecological cancer and their stable partners (ten dyads) will evaluate the content and delivery method of the intervention through self-report questionnaires and a qualitative interview.

Conditions

Breast Cancer; Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychosexual Educational Partners Program (PEPP)

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

Group Type: EXPERIMENTAL

Psychosexual Educational Partner Program (PEPP)

Intervention Type: BEHAVIORAL

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

Interventions

Psychosexual Educational Partner Program (PEPP)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Breast Cancer Research Foundation

UNKNOWN

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel Arring, DNP, PhD, RN, OCN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41118642 (View on PubMed)

Other Identifiers

HUM00202063

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2021.071

Identifier Type: -

Identifier Source: org_study_id