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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

Will I have to stop taking my current medications?

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

Is the educational intervention for prostate cancer safe for humans?

The educational interventions for prostate cancer, such as group education sessions and multimedia programs, are generally safe and focus on providing information to help patients make informed decisions about their treatment. These interventions aim to reduce anxiety and improve understanding, with no reported safety concerns. ^{1 2 3 4 5}

How does this educational intervention treatment for prostate cancer differ from other treatments?

This educational intervention for prostate cancer is unique because it focuses on empowering patients with knowledge and self-efficacy, helping them make informed decisions about their treatment options. Unlike traditional medical treatments, it uses multimedia tools and community-based programs to enhance understanding and support, addressing the psychosocial aspects of living with prostate cancer. ^{3 5 6 7 8}

What data supports the effectiveness of the treatment Educational intervention, Simulation-based education, Interdisciplinary counseling training for prostate cancer?

Research shows that educational programs can improve understanding of prostate cancer, leading to better treatment outcomes and patient satisfaction. An evidence-based education package significantly improved knowledge, quality of life, and satisfaction for men with prostate cancer, highlighting the importance of education in managing the disease. ^{2 3 9 10 11}

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]

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]

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 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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Ireland pubmed.ncbi.nlm.nih.gov

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

3. Canada 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. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Assessment of content completeness and accuracy of prostate cancer patient education materials. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Confidence of Nursing Personnel in Their Understanding Of the Psychosocial Impact of Prostate Cancer. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Examining the association of health literacy and numeracy with prostate-related knowledge and prostate cancer treatment regret. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Educating our patients collaboratively: a novel interprofessional approach. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Empowerment-Based Education in Urological Patients: A Scoping Review. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Psychosocial and educational aspects in prostate cancer patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer in African American men: increasing knowledge and self-efficacy. [2022]