Patient Empowerment Program for Prostate Cancer

(PC-PEP Trial)

Recruiting at 6 trial locations

Overseen By Rob Rutledge, MD, FRCPC

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Recent myocardial infarction, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help men who have had prostate cancer improve their quality of life after treatment. It tests a program designed to teach life skills that can boost mental health, fitness, and overall well-being while reducing side effects like urinary issues and sexual dysfunction. Men diagnosed with prostate cancer who can exercise might be a good fit for this study. Participants need to be comfortable using email and watching online videos as part of the program.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance post-treatment life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this program is safe for prostate cancer survivors?

Research shows that the Prostate Cancer Patient Empowerment Program (PC-PEP) is generally easy for participants to handle. In a study with 30 men over 28 days, the program received a high satisfaction score of 9.79 out of 10, indicating that participants found it helpful and simple to follow. Additionally, studies have shown that PC-PEP can help reduce stress and support weight loss in men with prostate cancer. Participants have reported no major side effects, suggesting that the program is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Empowerment Program for prostate cancer because it offers a novel approach to managing the condition. Unlike traditional treatments such as surgery, radiation, or hormone therapy, which focus on directly targeting cancer cells, this program emphasizes patient education and self-management. It aims to enhance patients' understanding of their condition and treatment options, thereby empowering them to make informed decisions about their care. This approach has the potential to improve patients' quality of life and engagement in their own health, which can lead to better overall outcomes.

What evidence suggests that the Patient Empowerment Program is effective for improving quality of life in prostate cancer survivors?

Studies have shown that the Prostate Cancer Patient Empowerment Program (PC-PEP), which participants in this trial will receive, can improve the quality of life for men who have undergone prostate cancer treatment. Research indicates that PC-PEP reduces stress and anxiety by 30%, greatly benefiting mental health. The program also strengthens relationships and boosts emotional well-being. Past participants rated the program highly, with an average score of 9.79 out of 10. Additionally, PC-PEP lowers healthcare costs, providing an added benefit. Overall, the program enhances life for prostate cancer survivors by teaching practical life skills and habits. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men over 18 with prostate cancer who can exercise moderately, use email and the internet, understand English, and are expected to live more than 2 years. They must be able to fill out surveys and watch videos online. Men unfit for low-level exercise or without internet access cannot join.

Inclusion Criteria

Ability and willingness to fill out an online survey at baseline, and 6, 12 and 24 months, and a weekly compliance survey for the six months of the program.

I am cleared by my doctor to exercise and do strength training.

I am older than 18 years.

Exclusion Criteria

Patients deemed unfit to participate in low level exercise eg. including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.

Unable to access the internet and lack of a computer or cellphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.

My doctor expects I have less than 2 years to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Prostate Cancer Patient Empowerment Program (PC-PEP) intervention aimed at improving mental health, fitness levels, and overall quality of life for six months

6 months

In-person and multimedia sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mental health, quality of life, and other health-related outcomes

6 - 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Empowerment Program

Trial Overview The Prostate Cancer Patient Empowerment Program (PC-PEP) is being tested on 400 men to improve their mental health, fitness levels, quality of life, and reduce side effects from treatments like surgery or radiation therapy.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

The Norwegian version of the Expanded Prostate Cancer Index Composite (EPIC-26) demonstrated acceptable reliability and validity for assessing adverse effects in patients with non-metastatic prostate cancer, based on a study involving 471 patients.

Psychometric testing showed strong internal consistency and significant correlations with established measures, indicating that EPIC-26 is a useful tool for evaluating patient-reported outcomes after treatments like radical prostatectomy or radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric testing of the Norwegian version of the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26). Fosså, SD., Storås, AH., Steinsvik, EA., et al.[2017]

In a study of 266 low-risk prostate cancer patients who underwent nerve-sparing radical prostatectomy, 75.1% reported being satisfied with their outcomes, highlighting the importance of patient education in achieving high satisfaction rates.

The study found that effective counseling on stress urinary incontinence (SUI) and erectile dysfunction (ED) significantly influenced long-term satisfaction, with poor education leading to lower satisfaction rates, emphasizing the need for thorough perioperative patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative patient education improves long-term satisfaction rates of low-risk prostate cancer patients after radical prostatectomy. Kretschmer, A., Buchner, A., Grabbert, M., et al.[2018]

This scoping review analyzed 64 studies on patient empowerment in cancer care, revealing that the concept of empowerment is often vaguely defined and measured, highlighting the need for clearer definitions and standardized measurement tools.

Nurses play a crucial role in patient empowerment, and to maximize its benefits, they should be trained in empowerment strategies and understand how to effectively engage patients throughout their cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Empowerment in Cancer Care: A Scoping Review. Kim, SH., Choe, YH., Kim, DH.[2023]

The 28-day Prostate Cancer-Patient Empowerment Program (PC-PEP) was well-received by 30 prostate cancer patients, who rated its usefulness at 9 out of 10, indicating its effectiveness in promoting both mental and physical health.

Participants appreciated the comprehensive nature of the program, which included education, physical activities, and social support, suggesting that integrating PC-PEP into standard care from the start of diagnosis could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Efficacy of a 28-Day Comprehensive Online Prostate Cancer Patient Empowerment Program (PC-PEP) in Facilitating Engagement of Prostate Cancer Patients in Their Survivorship Care: A Qualitative Study. Ilie, G., MacDonald, C., Richman, H., et al.[2023]

The German Urological Association has implemented various patient empowerment initiatives, such as the Entscheidungshilfe Prostatakrebs, which has over 12,000 users and aims to enhance patient autonomy in decision-making regarding prostate cancer treatment.

A randomized evaluation study involving 1200 participants is nearing completion to assess the effectiveness of these decision aids, highlighting the commitment to improving long-term treatment satisfaction and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Empowerment for our patients : Innovation in everyday urology]. Huber, J., Karschuck, P., Groeben, C., et al.[2022]

One year after surgery for localized prostate carcinoma, 25% of patients reported a negative assessment of their therapy success, highlighting the importance of patient satisfaction in treatment outcomes.

Key factors influencing patient assessments included urinary incontinence, sexual impotence, younger age, and higher risk of cancer recurrence, suggesting that addressing these issues could improve perceived therapy success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The assessment of therapy success after radical prostatectomy]. Köhler, N., Gansera, L., Holze, S., et al.[2019]

The increasing survival rates for men with prostate cancer highlight the need to evaluate not just survival, but also the quality of life during and after treatment.

Various health outcome improvement initiatives are being implemented at local, national, and international levels to assess and enhance the quality of survival for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer outcomes: the three questions. Glaser, AW., Corner, JL.[2015]

Many prostate cancer patients feel they have limited opportunities to communicate with their healthcare providers, which can affect their sense of empowerment during treatment.

Patients expressed a need for better support in decision-making and self-management, especially after diagnosis and surgery, highlighting the importance of personalized care and social support in enhancing their empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Investigation on Patient Empowerment in Prostate Cancer. Renzi, C., Fioretti, C., Oliveri, S., et al.[2020]

The CaPSURE database, which includes data from 1419 prostate cancer patients across 21 sites, aims to assess the impact of prostate cancer on clinical outcomes, quality of life, and resource utilization over time.

With 20% of participants newly diagnosed and an average diagnosis age of 68.9 years, the study highlights the diverse treatment approaches (surgery, irradiation, hormonal therapy, and watchful waiting) and their implications for patient well-being and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CaPSURE database: a methodology for clinical practice and research in prostate cancer. CaPSURE Research Panel. Cancer of the Prostate Strategic Urologic Research Endeavor. Lubeck, DP., Litwin, MS., Henning, JM., et al.[2022]

In a study involving 54 patients with metastatic castration-resistant prostate cancer (mCRPC), patient-reported outcomes (PROs) revealed that 89% of those receiving docetaxel experienced fatigue that interfered with daily activities, significantly higher than the 53% reported in registration studies.

The findings highlighted that several symptoms affecting daily life, which were reported by patients, were not commonly noted in official registration studies, suggesting that PROs can provide valuable insights into treatment side effects that may influence treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes interfering with daily activities in prostate cancer patients receiving antineoplastic treatment. Stormoen, DR., Baeksted, C., Taarnhøj, GA., et al.[2022]

In a study of 1,759 patients with localized or locally advanced prostate cancer, those who underwent radical prostatectomy experienced a significant increase in urinary incontinence, with 15% reporting this issue 24 months post-surgery, highlighting the need for awareness of this potential side effect.

Erectile dysfunction was also prevalent, with 87% of patients who had radical prostatectomy reporting ED after 24 months, compared to 41% after radiotherapy, indicating that surgical treatment has a substantial impact on sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary incontinence and erectile dysfunction in patients with localized or locally advanced prostate cancer: A nationwide observational study. Vernooij, RWM., Cremers, RGHM., Jansen, H., et al.[2022]

In two large clinical trials involving nearly 2300 patients with metastatic castration-resistant prostate cancer, improvements in patient-reported outcomes (PROs) like fatigue and functional well-being were linked to longer overall survival and longer time to disease progression.

Worsening PROs, particularly in physical well-being, were associated with a higher likelihood of disease progression, suggesting that monitoring these self-reported measures can help predict clinical outcomes in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between patient-reported outcomes and clinical outcomes in metastatic castration-resistant prostate cancer: post hoc analysis of COU-AA-301 and COU-AA-302. Cella, D., Traina, S., Li, T., et al.[2022]

A new standardized Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) subset was developed specifically for monitoring adverse events in prostate cancer patients, based on input from 30 patients and 16 healthcare providers.

The final subset includes 12 key adverse events such as erectile dysfunction, urinary issues, and emotional distress, with 90% consensus among participants, highlighting the importance of capturing patient experiences for better care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure. Feldman, E., Pos, FJ., Smeenk, RJ., et al.[2023]

In a review of 21 randomized controlled trials involving 9040 patients with nonmetastatic prostate cancer, it was found that acute adverse events (AEs) were primarily reported by clinicians, while patient-reported outcomes (PROs) were underutilized, especially for late AEs.

The study highlights a gap in incorporating patient perspectives in reporting AEs related to radical radiation therapy, suggesting a need for standardized PRO assessments to better capture patient experiences and improve treatment evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials. Holch, P., Henry, AM., Davidson, S., et al.[2022]

Patient empowerment (PE) for cancer patients in follow-up is defined as the ability to manage their treatment and care, including the option to refuse treatment and seek healthcare support when needed.

The study identified three key aspects of PE: the perception of control over treatment, possessing knowledge about their care, and the ability to communicate their needs to the healthcare system, highlighting the importance of tailoring support to individual patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptualizing patient empowerment in cancer follow-up by combining theory and qualitative data. Johnsen, AT., Eskildsen, NB., Thomsen, TG., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40893098/

Evaluating the cost-effectiveness of the Prostate Cancer ... Results: PC-PEP resulted in cost savings of $411.53 CAD per patient at six months, with a 30% reduction in clinically significant psychological ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03660085

Study Details | NCT03660085 | Prostate Cancer - Patient ... A PC-PEP feasibility study of 30 men, over 28 days, showed that the program is feasible, leads to positive outcomes in patients and is highly (9.79/10) endorsed ...

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. cuaj.ca cuaj.ca/index.php/journal/article/download/9222/6546/53570

Cost-effectiveness of the PCa Patient Empowerment Program Cost-effectiveness of the PCa Patient Empowerment Program​​ outcome, no statistically significant age-related differences were observed at six ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10969418/

PC-PEP, a Comprehensive Daily Six-Month Home-Based ... A comprehensive daily six-month home-based patient empowerment program leads to weight loss in men with prostate cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10930549/

Six-Month Prostate Cancer Empowerment Program (PC ... This Figure presents a detailed comparison of outcome measures between the control group and participants in the Prostate Cancer Patient ...