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

Trial Summary

What is the purpose of this trial?

Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.

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 data supports the effectiveness of the Patient Empowerment Program treatment for prostate cancer?

Research shows that patient education, a key part of empowerment programs, can improve long-term satisfaction for prostate cancer patients after surgery. This suggests that empowering patients with information and support may enhance their overall treatment experience. ^{1 2 3 4 5}

Is the Patient Empowerment Program for Prostate Cancer safe for humans?

The research articles focus on patient-reported outcomes and adverse events in prostate cancer treatments, highlighting the importance of monitoring symptoms directly from patients. While they do not specifically address the safety of the Patient Empowerment Program, they emphasize the need for understanding adverse effects in prostate cancer treatments. ^{6 7 8 9 10}

How does the Patient Empowerment Program for Prostate Cancer differ from other treatments?

The Patient Empowerment Program for Prostate Cancer is unique because it is a comprehensive, online, home-based program that includes daily education and empowerment videos, physical activities, a mostly plant-based diet, stress reduction techniques, and social support. This multifaceted approach helps patients engage in their care and manage emotional and physical challenges, making it more effective than single or less comprehensive interventions. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[The assessment of therapy success after radical prostatectomy]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate cancer outcomes: the three questions. [2015]

4. Sweden pubmed.ncbi.nlm.nih.gov

Psychometric testing of the Norwegian version of the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26). [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Perioperative patient education improves long-term satisfaction rates of low-risk prostate cancer patients after radical prostatectomy. [2018]

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

Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure. [2023]

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

Patient reported outcomes interfering with daily activities in prostate cancer patients receiving antineoplastic treatment. [2022]

8. United States 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. [2022]

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

Urinary incontinence and erectile dysfunction in patients with localized or locally advanced prostate cancer: A nationwide observational study. [2022]

10. England 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. [2022]

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

Patient Empowerment in Cancer Care: A Scoping Review. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Qualitative Investigation on Patient Empowerment in Prostate Cancer. [2020]

13. Switzerland 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. [2023]

14. Germany pubmed.ncbi.nlm.nih.gov

[Empowerment for our patients : Innovation in everyday urology]. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Conceptualizing patient empowerment in cancer follow-up by combining theory and qualitative data. [2022]