Your session is about to expire
← 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 belowSelect...
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
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
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.
Find a Location
Who is running the clinical trial?
The University of Tennessee, KnoxvilleLead Sponsor
83 Previous Clinical Trials
18,469 Total Patients Enrolled
2 Trials studying Breast Cancer
7 Patients Enrolled for Breast Cancer
Noel M Arring, DNP, PhD, RNPrincipal InvestigatorUniversity of Tennessee Knoxville
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger