Prostate Cancer-Patient Empowerment Program (PC-PEP) randomized clinical trial: Results of a six-month intervention designed to reduce the burden of mental health among patients with curative disease
Gabriela Ilie1,2,3, Ricardo A. Rendon1, Ross Mason1, Cody MacDonald2, Mike Kucharczyk3, Nikhilesh Patil3, Bowes David3, Gregory Bailly1, David Bell1, Joseph Lawen1, Michael Ha3, Wilke Derek3, Peter Massaro1, Jeff Zahavich4, Rob Rutledge3.
1Department of Urology, Dalhousie University, Halifax, NS, Canada; 2Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada; 3Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada; 4Department of Kinesiology, Dalhousie University, Halifax, NS, Canada
Dalhousie Research Medical Foundation - Soillse Fund (Principle Investigator: GI). Prostate cancer patients who donated their time and personal health history to this project. . PC-PEP Research Citizens and Mentors, for their engagement in the program and its development.. The team acknowledges the Soillse Lab team of trainees and staff.. Urology nurses: Getty Vasista, Barbara Ross, Liette Connor, Jessica Davis, and Emmi Champion.. The team acknowledges the support of the Nova Scotia Cancer Program, Marianne Arab and Leslie Hill.. Research Nova Scotia, for an Establishment Grant #2215 (PI: GI, Co-I: RR, RR, RM, GB, DB).
Introduction: Curative prostate cancer often co-occurs with poor mental health and elevated side-effects.1-2 Here, we examined the effects of a six-month, online, home-based intervention, Prostate Cancer–Patient Empowerment Program (PC-PEP), on reducing psychological distress and need for treatment among men with curative disease treated with radical prostatectomy or radiation therapy.
Methods: A randomized controlled trial was conducted involving 128 men with biopsy-proven prostate adenocarcinoma. Men were randomly assigned to receive the PC-PEP intervention (n=66) or standard of care (n=62) for six months. Non-specific psychological distress measured at baseline and at six months, measured using Kessler Psychological Distress Scale, was the primary outcome. Total and cuffoff (≥20) scores were assessed in covariate-adjusted analyses
Results: All 128 men completed the study (Table 1). Statistically significant interactions (time by condition) on non-specific psychological distress revealed that patients who received the intervention had significantly lower psychological distress than controls at six months (Figure 1). Patients in the control condition had 3.35 (95% confidence interval 1.06–10.52) times higher odds of screening positive for clinical non-specific psychological distress and need for treatment than men who received the intervention.
Conclusions: Results support the integration of PC-PEP to complement the standard of care and help reduce the burden of mental health of patients with curative disease.
[1] Brunckhorst, O., Hashemi, S., Martin, A., George, G., Van Hemelrijck, M., Dasgupta, P., Stewart, R., & Ahmed, K. (2021). Depression, Anxiety and Suicidality in Patients with Prostate Cancer: a Systematic Review and Meta-Analysis of Observational Studies. Prostate Cancer and Prostatic Diseases, 24(2), 281-289.https://doi.org/10.1038/s41391-020-00286-0
[2] Jayadevappa R, Malkowicz SB, Chhatre S, Johnson JC, Gallo JJ. The burden of depression in prostate cancer. Psychooncology. 2012 Dec;21(12):1338-45. doi: 10.1002/pon.2032. Epub 2011 Aug 12. PMID: 21837637.
