Educational Programs for Cancer Survivors and Their Partners
(PEPP Trial)
NM
CK
Overseen ByCarrie K Lafferty, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Tennessee, Knoxville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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
NM
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.
See 6 more
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
Trial OverviewThe 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
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 Clinic Near You
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+
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