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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).

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 data supports the effectiveness of the treatment Patient Education for Prostate Cancer?

Research shows that educational programs can improve understanding of prostate cancer, leading to earlier diagnosis and better management of treatment and complications. An evidence-based education package significantly improved knowledge, quality of life, and satisfaction with care for men with prostate cancer on hormonal therapy. ^{1 2 3 4 5}

Is patient education generally safe for prostate cancer patients?

Patient education is generally considered safe and beneficial for prostate cancer patients, as it helps improve their knowledge, quality of life, and satisfaction with care. It does not pose any direct health risks and is an important part of cancer care. ^{2 6 7 8 9}

How does the patient education treatment for prostate cancer differ from other treatments?

This treatment is unique because it focuses on providing an evidence-based education package to improve patients' understanding of prostate cancer and its treatments, enhancing their quality of life and satisfaction with care. Unlike standard medical treatments, this approach emphasizes the importance of knowledge and informed decision-making in managing the disease. ^{1 2 4 10 11}

Research Team

Walter Stadler, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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. Ireland pubmed.ncbi.nlm.nih.gov

Informational needs of men with prostate cancer on hormonal manipulation therapy. [2019]

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

Information needs of early-stage prostate cancer patients: a comparison of nine countries. [2021]

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

The Effect of Intensive Education On Urinary Incontinence Following Radical Prostatectomy: A Randomized Control Trial. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. [2023]

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

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

8. Ireland pubmed.ncbi.nlm.nih.gov

Determining what patients should know about transurethral prostatectomy. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Patients and caregivers' unmet information needs in the field of patient education: results from an Italian multicenter exploratory survey. [2020]

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

Informing men about prostate cancer screening: a randomized controlled trial of patient education materials. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

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