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Behavioral Intervention

Educational Programs for Cancer Survivors and Their Partners (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
Must not have
Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (Defined per medical history and/or patient self-report)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up consent of first participant through study completion of last participant, up to 1 year
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I have a history of breast or gynecological cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an uncontrolled psychiatric disorder like major depression, bipolar, OCD, or schizophrenia.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dyadic Sexual Communication (DSC)
Secondary study objectives
Adherence rate
Adverse events
Self-Efficacy to Communicate about Sex and Intimacy (SECSI)

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
85 Previous Clinical Trials
18,682 Total Patients Enrolled
Noel M Arring, DNP, PhD, RNPrincipal InvestigatorUniversity of Tennessee Knoxville
1 Previous Clinical Trials
~0 spots leftby Sep 2024
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