Patient Education for Prostate Cancer

Overseen By Personalized Cancer Care Consortium

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: LHRH agonists, LHRH antagonists

Disqualifiers: More than 2 prior regimens

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an educational session about orchiectomy (surgery to remove the testicles) might influence decisions to choose this surgery over ongoing medical castration for prostate cancer treatment. Participants will either attend an educational session (Patient Education) or continue with their usual care, with both groups completing questionnaires. The goal is to determine if increased knowledge about the surgery affects decision-making. Men with metastatic prostate cancer who have been on hormone therapy for at least a year and can complete surveys in English may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding patient decision-making in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants should already be on continuous LHRH therapy, so you may need to continue that treatment.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs about prostate cancer are effective and safe. Studies have found that these programs significantly increase participants' knowledge about prostate cancer. For instance, one study discovered that after attending an educational session, participants immediately understood more about prostate cancer screening and felt more informed and confident in making health decisions.

No reports indicate negative effects from learning more about prostate cancer. Thus, the educational component of this trial is generally well-received. Participants attend a session and complete questionnaires, which poses very low risk.

In summary, educational programs are safe and can enhance confidence and understanding of prostate cancer care options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on patient education, a unique approach for prostate cancer management. Unlike traditional treatments such as surgery, radiation, or hormone therapy, this trial explores the impact of educating patients about orchiectomy—a surgical procedure to remove one or both testicles. The goal is to see if understanding their treatment options can improve patient outcomes and satisfaction. Educating patients empowers them to make informed decisions, potentially leading to better compliance and quality of life.

What evidence suggests that this educational intervention is effective for prostate cancer patients?

Research has shown that educational programs can significantly enhance prostate cancer patients' knowledge and assist them in making better health decisions. For example, one study found that these programs improved patients' understanding of prostate cancer and altered their preferences and actions. Another study, using a health belief model, demonstrated that education increased prostate cancer knowledge and positively influenced health beliefs. Additionally, a review of several studies found that educational programs improved the quality of life for men undergoing androgen deprivation therapy, a treatment to lower male hormones. In this trial, participants in the educational intervention arm will attend a short educational session about orchiectomy (surgical removal of the testicles), which may help them make more informed decisions about their care. ^{2 4 6 7 8}

Who Is on the Research Team?

Walter Stadler, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for men with advanced prostate cancer who have been on hormone therapy for at least a year and expect to continue it. They must be able to fill out surveys in English. Men who've had more than two types of systemic treatments besides castration can't join.

Inclusion Criteria

I have been diagnosed with advanced prostate cancer.

I have been on hormone therapy for over a year and expect to continue.

Able to complete written surveys in English

Exclusion Criteria

I have had more than two treatments for my cancer, in addition to hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants undergo a short educational session about orchiectomy and complete questionnaires

1 session

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction with their treatment decision using the Decision Regret Scale

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Patient Education

Trial Overview The study is looking into the effects of educating patients about orchiectomy, which is surgery to remove the testicles, as an alternative to ongoing medical hormone-blocking treatments for prostate cancer.

How Is the Trial Designed?

Group I: Educational Intervention Experimental Treatment 1 Intervention

Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.

Group II: No Intervention Active Control 1 Intervention

Participants that decline the education session will continue with routine care of their cancer. They will also be asked to complete questionnaires.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

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]

Intense bladder control education did not lead to improved bladder control in patients who had a radical prostatectomy for prostate cancer, indicating that traditional educational approaches may be ineffective.

Patients continued to experience bladder control issues post-surgery, highlighting the need for nurses to create and test new interventions to better address these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Intensive Education On Urinary Incontinence Following Radical Prostatectomy: A Randomized Control Trial. Novick, BJ., Angie, M., Walker, E., et al.[2015]

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 survey of 659 early-stage prostate cancer patients across nine countries identified a core set of 20 essential questions that over two-thirds of patients deemed important during their diagnosis-to-treatment decision-making process.

While there were common information needs among patients from different countries, significant variability existed in the specific questions considered essential, highlighting the importance of tailoring information to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs of early-stage prostate cancer patients: a comparison of nine countries. Feldman-Stewart, D., Capirci, C., Brennenstuhl, S., et al.[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]

Men with locally advanced prostate cancer undergoing hormonal manipulation therapy (HMT) in the UK showed significant knowledge deficits about their disease and treatment options, indicating a need for better education.

The study highlights the importance of addressing the informational needs of these patients, suggesting that providing evidence-based educational interventions could improve their understanding and coping mechanisms related to their diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informational needs of men with prostate cancer on hormonal manipulation therapy. Templeton, H., Coates, V.[2019]

In a randomized controlled trial involving 161 men over 45 who had never been screened for prostate cancer, different methods of presenting health information (video, internet, and written materials) showed no significant differences in reducing decisional conflict or improving knowledge, anxiety, and screening interest.

The study concluded that since all three methods were equally effective, healthcare providers should choose the method that best fits the patient's convenience and preferred learning style.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing men about prostate cancer screening: a randomized controlled trial of patient education materials. Ilic, D., Egberts, K., McKenzie, JE., et al.[2021]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

Cancer patient education should go beyond just providing information; it must also include teaching coping skills and new strategies to manage the disease, which can lead to better treatment adherence and reduced anxiety.

Focusing on the different phases of cancer care can help identify essential educational content, and ongoing research is crucial for developing effective teaching methods and evaluating their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and education across the phases of cancer care. Adams, M.[2019]

A survey of 875 users from Italian Cancer Research & Care Centers revealed a strong interest in patient education and empowerment (PEE) activities, with top priorities being early diagnosis (18%), prevention (17%), and understanding diagnosis (13%).

Nearly half of the respondents (49%) expressed a desire to participate in organizing PEE activities, particularly among caregivers and users over 55, highlighting the importance of face-to-face educational classes with healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients and caregivers' unmet information needs in the field of patient education: results from an Italian multicenter exploratory survey. Truccolo, I., Mazzocut, M., Cipolat Mis, C., et al.[2020]

A study involving 73 men who underwent transurethral prostatectomy revealed that patients desired more detailed information about the medical and sexual consequences of the surgery, indicating a gap in current patient education materials.

Providing clear written instructions, reassurance about recovery expectations, and addressing common concerns significantly improved patients' overall experience and satisfaction with the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining what patients should know about transurethral prostatectomy. Libman, E., Creti, L., Fichten, CS.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7445972/

Prostate Cancer-based Interventions' Efficacy on ... Educational program aimed at motivating men to increase their knowledge of prostate cancer and having adherence intention to a healthy lifestyle. Key Words: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4548640/

The impact of educational sessions provided on prostate ... Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors. J Gen ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12044-9

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

4. bmjopen.bmj.com bmjopen.bmj.com/content/14/5/e080310

Effectiveness of educational and psychological ... This systematic review aimed to identify educational and psychological survivorship interventions targeting HRQoL outcomes for men with prostate cancer on ADT ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125006792

Effectiveness in physical activity levels of Proactive ... The results of this study indicated a significant improvement in physical activity levels of prostate cancer survivors after implementing ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38438952/

Effect of health belief model-based educational ... Results: Participants' knowledge about prostate cancer screening improved significantly immediately after the program and this positive change ...

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.70010

Consensus‐built recommendations to improve prostate ... Prostate cancer outcomes are worsening, and notable disparities exist across multiple demographic groups. Cohesive guidelines around screening, ...

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

A Comprehensive 6-mo Prostate Cancer Patient ... The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient ...