← Back to Search

Behavioral Intervention

Self-Guided PEPP Intervention workbook for Breast Cancer (PEPP Trial)

N/A

Recruiting

Led By Noel M Arring, DNP, PhD, RN

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 female

History of any stage of breast and/or gynecological cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up consent of first participant through study completion of last participant, up to 1 year

Awards & highlights

PEPP Trial Summary

This trial aims to compare two educational programs for women who have finished treatment for breast or gynecological cancer and their partners. They will enroll 30 pairs in a small study to see how effective the

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions are educational workbooks, traditional medical side effects are not applicable. However, participants may experience emotional or psychological discomfort while discussing sensitive topics related to psychosexual communication.

PEPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18 or older.

Select...

I have a history of breast or gynecological cancer.

PEPP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ consent of first participant through study completion of last participant, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~consent of first participant through study completion of last participant, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and consent of first participant through study completion of last participant, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dyadic Sexual Communication (DSC)

Secondary outcome measures

Adherence rate

Adverse events

Self-Efficacy to Communicate about Sex and Intimacy (SECSI)

PEPP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Guided PEPP Intervention workbookExperimental Treatment1 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 WorkbookActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Tennessee, KnoxvilleLead Sponsor

83 Previous Clinical Trials

18,499 Total Patients Enrolled

2 Trials studying Breast Cancer

37 Patients Enrolled for Breast Cancer

Noel M Arring, DNP, PhD, RNPrincipal InvestigatorUniversity of Tennessee Knoxville

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively involved in this research endeavor?

"The details provided on clinicaltrials.gov indicate that this specific trial is actively searching for suitable participants. It was initially listed on February 1, 2024, with the latest update done on February 2, 2024. The study aims to recruit a total of 60 patients from one designated site."

Answered by AI

Are individuals older than 35 eligible to participate in this study?

"Recruitment for this study includes individuals above 18 years and under the age of 99."

Answered by AI

Are patients currently eligible to participate in this ongoing medical study?

"Indeed, information available on clinicaltrials.gov indicates that this research endeavor is actively enrolling participants. The trial was initially posted on February 1st, 2024 and last revised on February 2nd, 2024. A total of 60 individuals are sought after from a single site for inclusion in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psychosexual Educational Partners Program (PEPP)

Noel Arring 2024. "Psychosexual Educational Partners Program (PEPP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253182.

All > Breast Cancer Hawaii > Knoxville