Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Breast Cancer; Gynecologic Cancer

Treatments: Behavioral: Psychosexual Educational Partner Program (PEPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05070299

UMCC 2021.071

HUM00202063 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria below apply only to the patient. (The patient's partner must be 18 years of age or older.)

Patient 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.

Patient 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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Psychosexual Educational Partners Program (PEPP)

Experimental group

Description:

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

Treatment:

Behavioral: Psychosexual Educational Partner Program (PEPP)