Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program

In a survey study of almost 400 survivors of prostate cancer (PC), the investigators found that 17% of them suffered currently from mental health issues, and most were not on medication to address this issue. Compounding issues included urinary and sexual disfunction, poor attendance to support groups, intimacy, problems sleeping and other health problems. To address these many issues directly, with the endorsement of physicians and patients attending our regional PC integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery) science, the investigators created a Patient Empowerment Program (PEP) to be delivered from day one of diagnosis, to educate and teach the men and partners life skills/habits which are aimed to improve their fitness levels and quality of life, and to decrease treatment related side effects. This program is in line with the Auditor General of Nova Scotia's 2017 report endorsing the use of bottom-up evidence-based interventions, created from actively engaging patients in development and process. The investigators aim to trial PC-PEP for men undergoing curative treatment for PC versus a control group receiving standard care. The PC-PEP program includes in-person and multimedia informational, physical activity, pelvic floor, stress reduction, and relationship/connection training. The men are connected with other participants to increase social support and maximize compliance. Technology is used to deliver daily alerts to patients to remind them to engage in the program. 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 by patients. It is predicted that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.

A randomized, wait-list controlled clinical trial for men newly diagnosed with PC is currently underway. This next phase will open the program to more men and expand the inclusion criteria. Participants in the PC-PEP will receive the intervention for six months. Introducing a comprehensive empowerment program from day one of diagnosis may mitigate against the high levels of mental distress, short and long-term, suffered by hundreds of Nova Scotian men undergoing curative PC treatment every year, and the burden that treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at Nova Scotia Health, if proven successful it will have the evidence base needed to change the current standard of care.

• General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12) [Time frame: 6 - 24 months]
• Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) [Time frame: 6 - 24 months]
• Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) [Time frame: 6 - 24 months]
• Urinary Bother as assessed by the International Prostate Symptom Score (IPSS) [Time frame: 6 - 24 months]
• Health Care Utilization [Time frame: 6 - 24 months]
• Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS) [Time frame: 6 - 24 months]
• Diet as assessed by the Starting the Conversation (STC) Questionnaire [Time frame: 6 - 24 months]
• Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: 6 - 24 months]
• Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale) [Time frame: Baseline to 6 months; baseline to 12 months; baseline to 24 months.]
• Change in generalized anxiety symptoms (GAD-7) [Time frame: Baseline to 6 months; Baseline to 12 months, Baseline to 24 months.]