Clinical trial NCT06253182: Psychosexual Educational Partners Program (PEPP)
Official title: Psychosexual Educational Partners Program (PEPP): Randomized Phase II Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Sexual Dysfunction
Partner Communication
Keywords: breast cancer
gynecologic cancer
sexual dysfunction
partner communication
couples
intimacy
sexual health
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The Psychosexual Educational Partners Program (PEPP) is a two-arm pilot randomized controlled trial that will compare two approaches to a self-paced, workbook-based intervention. PEPP was designed to enhance intimacy among breast and gynecological cancer survivors and their partners by improving sexual communication. The primary aim of the study is to assess the preliminary efficacy of the revised PEPP intervention on sexual communication. Secondary aims include assessing the preliminary efficacy of PEPP on self-efficacy to communicate about sex and intimacy among cancer survivors; and evaluating adherence, acceptance and adverse events within each study arm.

The intervention is six weeks long and does not require any in-person visits. If a breast or gynecological cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, participants will be emailed the consent form and will schedule a virtual consent/baseline visit that will include their partner. After consent is obtained from both partners, the dyad will be randomly assigned to a study arm and given study numbers. Both members of the dyad will complete online surveys at the virtual baseline visit. The PEPP workbook will be sent to the participants' address and a virtual education visit will be scheduled. At this second virtual visit, both members of the dyad will receive education about their study arm and a start date will be agreed upon for week 1. Beginning week 1 and continuing through week 6, dyads will work through the PEPP workbook which contains three modules. Participants will receive a scheduled email and/or text check-in message from study staff every two weeks to coincide with the end of each module. Messages will provide a link to a brief survey to assess adherence and respond to any participant questions or concerns. Online surveys will be repeated and adverse events will be assessed at week 6.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 female.
2. Able to read and write in English.
3. History of any stage of breast and/or gynecological cancer.
4. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 10 years prior to registration.
5. May use maintenance therapy and concurrent adjuvant endocrine therapy or human epidermal growth factor receptor 2 negative (HER2-) targeted therapy while on study.
6. 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.
7. Responds yes to the question "Has there been a change in communication and/or intimacy with your partner since your cancer diagnosis?"
8. Both partner and woman patient must agree to participate in the study and sign informed consent to the study.
9. 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.

Exclusion Criteria:

1. Past history of sexual abuse.
2. Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (Defined per medical history and/or patient self-report).
3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).

Primary outcomes:
measure: Dyadic Sexual Communication (DSC)
timeFrame: consent through study completion, an average of 8 weeks
Secondary outcomes:
measure: Self-Efficacy to Communicate about Sex and Intimacy (SECSI)
timeFrame: consent through study completion, an average of 8 weeks
measure: Adherence rate
timeFrame: consent of first participant through study completion of last participant, up to 1 year
measure: Adverse events
timeFrame: consent through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Knoxville
state: Tennessee
Study officials:
affiliation: University of Tennessee Knoxville
name: Noel M Arring, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: