Educational Intervention for Prostate Cancer

(IMPRINT Trial)

Overseen By Rana McKay, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Prior germline testing, Positive somatic test

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the number of men with prostate cancer who undergo germline testing, which identifies inherited genetic mutations that could influence treatment or family risk. The trial employs an educational intervention, known as simulation-based education or interdisciplinary counseling training, delivered either in person or online, to inform participants about the benefits and process of germline testing. Men with prostate cancer who have not previously undergone this type of genetic testing are ideal candidates for the trial. As an unphased trial, it provides participants with the opportunity to gain valuable insights into their genetic health and potentially enhance their treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs, like the one in this trial, are generally safe for participants. One study examined peer-based education about genetic testing for prostate cancer and found it increased understanding without harmful effects. Another study demonstrated that educational sessions can enhance knowledge and attitudes about health without causing negative effects.

These findings suggest that educational programs, whether in-person or online, are well-received. They improve understanding and attitudes about health topics without known risks to participants. Therefore, joining this educational session should be safe and informative. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on an educational intervention for prostate cancer, specifically aimed at improving understanding of germline testing. Unlike traditional treatments such as surgery, radiation, or hormone therapy, which directly target the cancer itself, this intervention empowers patients through knowledge. By providing in-clinic or virtual sessions with trained educators, the approach aims to enhance patient decision-making and potentially improve outcomes by ensuring patients are better informed about their genetic risks and treatment options. This educational strategy is unique because it addresses the often-overlooked aspect of patient education in cancer care, which can lead to more personalized and effective treatment plans.

What evidence suggests that this educational intervention is effective for improving germline testing rates in prostate cancer?

Research has shown that educational programs effectively increase knowledge and improve attitudes about prostate cancer. In this trial, participants will receive an educational intervention, including in-clinic or virtual sessions on germline testing in prostate cancer with a trained educator. One study found that education based on the health belief model led to better understanding and healthier views about prostate cancer. Another study demonstrated that educational sessions greatly improved knowledge, confidence in taking action, and social support. These findings suggest that attending an educational session can significantly aid in understanding and managing prostate cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Rana McKay, MD

Principal Investigator

UCSD

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older who have been diagnosed with prostate cancer and meet the NCCN guidelines for germline testing. It's not open to those who've already had germline testing or have positive somatic genetic tests suggesting a possible inherited variant.

Inclusion Criteria

I qualify for genetic testing based on national cancer guidelines.

I have been diagnosed with prostate cancer.

Exclusion Criteria

I have undergone genetic testing.

My genetic test shows a possible inherited mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants undergo a one-on-one educational session regarding the rationale and benefits/risks of germline testing

1 session

1 visit (in-person or virtual)

Germline Testing

Participants who consent proceed with germline testing via a commercial assay

1-2 weeks

Follow-up

Participants are monitored for changes in knowledge and attitudes towards germline testing, and the impact on prostate cancer management

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational intervention

Trial Overview The study is examining the effectiveness of an educational session held in clinics aimed at increasing the rate of genetic testing among men with prostate cancer to identify inherited variants.

How Is the Trial Designed?

Group I: Educational intervention Experimental Treatment 1 Intervention

In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Patients with low socioeconomic status and/or low literacy face significant challenges in managing prostate cancer, highlighting the need for targeted educational programs to improve their understanding and treatment outcomes.

Involving practice nurses and health educators can enhance patient engagement in treatment decisions and improve posttreatment follow-up, leading to better management of complications and earlier diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the low-socioeconomic-status prostate cancer patient. Rayford, W.[2021]

There is an increasing focus on the psychosocial challenges faced by prostate cancer patients, highlighting the need for educational and group interventions to address these issues.

Research has identified various unmet needs among prostate cancer patients, including information and support related to diagnosis, treatment, and quality of life, indicating significant areas for improvement in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and educational aspects in prostate cancer patients. Visser, A., van Andel, G.[2019]

The Prostate Interactive Educational System (PIES) was well accepted by 72 patients with newly diagnosed localized prostate cancer, enhancing their treatment decision-making process without disrupting clinical routines.

Patients using PIES reported greater confidence in their treatment choices, found the information more helpful and reassuring, and experienced less anxiety compared to those receiving standard information, indicating that PIES effectively supports patients in navigating their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and preliminary feasibility of an internet/CD-ROM-based education and decision program for early-stage prostate cancer patients: randomized pilot study. Diefenbach, MA., Mohamed, NE., Butz, BP., et al.[2021]

A randomized controlled trial involving 55 men with prostate cancer showed that an evidence-based education package significantly improved their knowledge about the disease, quality of life, and satisfaction with care while undergoing hormonal manipulation therapy.

The education package, which included an information booklet and verbal teaching from a urology nurse, should be routinely integrated into care for prostate cancer patients, as it effectively addresses their informational needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy. Templeton, H., Coates, V.[2015]

A scoping review of 3,197 articles identified 42 relevant studies highlighting the need for cognitive, psychological, and functional support for urological patients undergoing surgeries like prostatectomy, cystectomy, and nephrectomy.

Various educational strategies, such as informational brochures, preoperative counseling, and online content, can effectively help patients manage the negative effects of their conditions and treatments, empowering them to take charge of their disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment-Based Education in Urological Patients: A Scoping Review. Villa, G., Galli, E., Azzimonti, V., et al.[2022]

A review of educational intervention trials in prostate cancer over the last 10 years revealed that most studies focused on managing the disease, treatments, and side effects, highlighting the importance of education in patient care.

Understanding psychosocial stressors and educational interventions is essential for nurses, as these factors significantly impact the well-being of men with prostate cancer and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and educational intervention trials in prostate cancer. Germino, BB.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116859/

a systematic review This systematic review aimed to identify educational and psychological survivorship interventions targeting HRQoL outcomes for men with prostate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913411/

Effect of health belief model-based educational ... Our research objective was to investigate the effect of health belief model-based education on prostate cancer knowledge, health beliefs, and preventive health ...

3. researchgate.net researchgate.net/publication/380797003_Effectiveness_of_educational_and_psychological_survivorship_interventions_to_improve_health-related_quality_of_life_outcomes_for_men_with_prostate_cancer_on_androgen_deprivation_therapy_a_systematic_r

(PDF) Effectiveness of educational and psychological ... Conclusions: Findings from this study suggest virtual post-surgical care delivered via videoconferencing is highly acceptable to prostate cancer ...

4. brachyjournal.com brachyjournal.com/article/S1538-4721(20)30184-7/fulltext

Development, implementation, and outcomes of a simulation ... A 1-week simulation-based medical education course for LDR-PB can improve didactic performance and self-reported technical competence/confidence ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/10547738211051011

The Effect of Educational Intervention Based on PRECEDE ... Six months after intervention, experimental group showed significant increase in knowledge, attitude, self-efficacy, enabling factors, social supports, health ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0027968425000409

Utilizing peer educators to increase genetic testing for ... We aimed to evaluate the impact of a peer-based educational intervention about PCa genetic testing for Black males in a community setting.