Educational Programs for Cancer Survivors and Their Partners

(PEPP Trial)

Overseen by Noel M Arring, DNP, PhD, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Tennessee, Knoxville

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Noel M Arring, DNP, PhD, RN

Principal Investigator

University of Tennessee Knoxville

Eligibility Criteria

This trial is for women who have finished treatment for breast or gynecological cancer and their partners. It aims to help with sexual communication post-treatment. The study will include 30 pairs (dyads) of patients and partners, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Able to read and write in English

I am a woman aged 18 or older.

I can continue hormone therapy or HER2- treatment while in the study.

Exclusion Criteria

Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)

I do not have an uncontrolled psychiatric disorder like major depression, bipolar, OCD, or schizophrenia.

Past history of sexual abuse

Treatment Details

Interventions

• PEPP (Behavioral Intervention)

Trial Overview The study is testing two educational programs designed to improve psychosexual health: a self-guided PEPP Education Workbook and a self-guided PEPP Intervention Workbook. Participants will be randomly placed into one of the two groups in this pilot randomized controlled trial.

Participant Groups

Group I: Self-Guided PEPP Intervention workbook Experimental Treatment 1 Intervention

Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns.

Group II: Self-Guided PEPP Education Workbook Active Control 1 Intervention

Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Randy Boyd

The University of Tennessee, Knoxville

Chief Executive Officer since 2019

Bachelor's degree from the University of Tennessee, Knoxville

Dr. Ogram

The University of Tennessee, Knoxville

Chief Medical Officer since 2018

PhD in Microbiology with a concentration in Molecular Virology from the University of Tennessee, Knoxville

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+