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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well two educational programs can improve sexual communication between women who have had breast or gynecological cancer and their partners. The study will test two different versions of a workbook that participants will complete independently, with regular check-ins. Women who completed their primary cancer treatment in the last 3 to 10 years and have noticed changes in their relationship communication are ideal candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance relationship communication for many others in similar situations.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. You can continue maintenance therapy, adjuvant endocrine therapy, and certain psychiatric medications if you've been on them for at least 30 days before joining the study.

What prior data suggests that these educational programs are safe?

Studies have shown that programs like PEPP, including the Cancer Patient Empowerment Program (PC-PEP), are generally safe for participants. People who have completed cancer treatment find these programs manageable. Research indicates that these programs can reduce stress and enhance overall well-being without causing harm.

Participants in these programs did not report any major negative side effects. Many experienced emotional improvement and better relationships. This suggests that the PEPP program should also be safe for participants. However, discussing any concerns with a healthcare professional before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEPP educational programs for cancer survivors and their partners because they offer a fresh approach to support and education. Unlike traditional in-person support groups or counseling sessions, PEPP leverages a self-guided workbook that participants can navigate at their own pace in the comfort of their home. This method not only provides flexibility but also ensures continuous engagement through regular check-ins via email or text, which is a unique feature compared to standard options. By empowering participants to independently work through the program with periodic guidance, PEPP aims to enhance adherence and address personal concerns effectively.

What evidence suggests that this trial's educational programs could be effective for cancer survivors and their partners?

Research shows that educational programs like PEPP (Psychosexual Educational Partners Program) can benefit cancer survivors. This trial will evaluate two versions of the PEPP program: the Self-Guided PEPP Intervention Workbook and the Self-Guided PEPP Education Workbook. Studies on similar programs have found that they greatly reduce stress and improve emotional health for cancer patients. These programs also help maintain strong relationships, which is important for both patients and their partners. Although specific data on PEPP's effectiveness is still being collected, early results from similar programs are encouraging. They suggest that these educational programs could enhance communication between partners, including about sexual matters. ^{1 4 5 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475673/

The Cancer Patient Empowerment Program A randomized controlled trial (RCT) of PC-PEP showed substantial reductions in psychological distress and improved oncological outcomes [7,8,9,10]. However, the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528560/

PMC Search Update - PubMed Central - NIH This study aims to explore the perceptions of patients regarding a 28-day online Prostate Cancer-Patient Empowerment Program (PC-PEP). The ...

3. researchgate.net researchgate.net/publication/384578787_The_Cancer_Patient_Empowerment_Program_A_Comprehensive_Approach_to_Reducing_Psychological_Distress_in_Cancer_Survivors_with_Insights_from_a_Mixed-Model_Analysis_Including_Implications_for_Breast_Cance

(PDF) The Cancer Patient Empowerment Program Our findings indicate that while CancerPEP significantly reduced psychological distress and improved emotional well-being across cancer patients ...

4. mdpi.com mdpi.com/1718-7729/31/10/479

Assessing the Impact of the Prostate Cancer Patient ... Conclusions: The PC-PEP program effectively maintains relationship satisfaction and enhances emotional well-being, particularly in patients with ...

5. europeanurology.com europeanurology.com/article/S0302-2838(23)02581-2/fulltext

A Comprehensive 6-mo Prostate Cancer Patient ... PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39409993/

The Cancer Patient Empowerment Program This study aimed to evaluate the feasibility, accrual and attrition rates, safety, and effectiveness of the CancerPEP intervention, with and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0302283823025812

A Comprehensive 6-mo Prostate Cancer Patient ... PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment ...