Psychosexual Educational Partners Program to Improve Sexual Health Outcomes in Women with Breast or Gynecologic Cancer, The PEPP STUDY

Status: complete

This clinical trial tests a psychosexual education partner program (PEPP) to improve sexual health outcomes in women with breast or gynecologic cancers. Female cancer survivors may experience long term effects from their cancer diagnosis and/or treatment including hot flashes, night sweats, sleep changes, fatigue, and diminishing sexual function, including vaginal atrophy (decreased arousal, dryness, and painful intercourse), decreased desire, and negative self-image. These physical changes and emotional challenges faced by survivors may impact the way a couple relates to each other and what they relate about. Intimacy may be interrupted, even avoided. Usual couple interactions can be put on a hiatus while the need to cope with the daily stressors of treatment take priority. PEPP focuses on relationship/partner concerns and may help patients and their partners improve communication and intimacy.

Inclusion Criteria

Age >= 18 female.
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 HER 2-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 patient must agree to participate in the study and sign informed consent to the study.

Exclusion Criteria

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).

PRIMARY OBJECTIVE:

I. Assess the feasibility of the Psychosexual Educational Partners Program (PEPP).

SECONDARY OBJECTIVES:

I. Evaluate participants’ experience with the intervention.

II. Explore the PEPP’s impact on sexual health, sexual communication and relationship quality as measured by PROMIS Sexual Function (PROMIS SexF), Dyadic Sexual Communication (DSC), and the Revised Dyadic Adjustment Scale (RDAS).

OUTLINE:

Patients and partners complete a 3 module workbook together over a 6 week period and participate in a 30 minute follow up phone call with study staff at the completion of each module. Upon completion of all modules and phone calls, patients complete online follow-up surveys and a 1 hour video recorded interview.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Psychosexual Educational Partners Program to Improve Sexual Health Outcomes in Women with Breast or Gynecologic Cancer, The PEPP STUDY

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help