Educational Programs for Cancer Survivors and Their Partners

(PEPP Trial)

Overseen By Carrie K Lafferty, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Disqualifiers: Sexual abuse, Uncontrolled psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Noel M Arring, DNP, PhD, RN

Principal Investigator

University of Tennessee Knoxville

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 virtual visit

Treatment

Participants engage in a self-paced, workbook-based intervention over six weeks

6 weeks

2 virtual visits

Follow-up

Participants are monitored for adherence, acceptance, and adverse events after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PEPP

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.

How Is the Trial Designed?

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+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+