A Comprehensive 6-mo Prostate Cancer Patient Empowerment Program Decreases Psychological Distress Among Men Undergoing Curative Prostate Cancer Treatment: A Randomized Clinical Trial

BACKGROUND: Although survival rates for newly diagnosed prostate cancer patients are very high, most of them will likely suffer significant treatment-related side effects, depression, or anxiety, affecting their quality of life. OBJECTIVE: The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient Empowerment Program (PC-PEP), on preventing psychological distress among men undergoing curative prostate cancer treatment. DESIGN, SETTING, AND PARTICIPANTS: In a crossover randomized clinical trial of 128 men aged 50-82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone treatment), 66 received the 6-mo PC-PEP intervention and 62 were randomized to a waitlist-control arm and received the standard of care for 6 mo, and then PC-PEP to the end of the year. The PC-PEP intervention consisted of daily e-mails with video instructions providing education, patient activation, and empowerment on healthy living including physical and mental health, dietary recommendations, social support, physical and pelvic floor fitness, stress reduction using a biofeedback device, social connection and intimacy, and social support. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was nonspecific psychological distress (clinical cutoff ≥20) measured at baseline, and at 6 and 12 mo using the Kessler Psychological Distress Scale (K10). RESULTS AND LIMITATIONS: At 6 mo, patients in the waitlist-control group had 3.59 (95% confidence interval: 1.12-11.51) times higher odds for nonspecific psychological distress and need for psychological treatment than men who received the PC-PEP intervention. At 12 mo, the wait-list control group that received the intervention at 6 mo had higher psychological distress than the early group. CONCLUSIONS: PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment compared with standard of care, or late (6 mo later) intervention. PATIENT SUMMARY: In this report, we looked at the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients' engagement on the mental distress of patients awaiting curative treatment for their prostate cancer. The PC-PEP program lasted for 6 mo, and it prescribed, described, and demonstrated daily aerobic and strength training, kegels (pelvic floor training to help with urinary and sexual function), dietary changes that have been shown to be helpful in the prevention of prostate cancer and prostate cancer progression, stress reduction using a biofeedback device, as well as social and emotional support. All patients in the PC-PEP program were invited to a monthly video conference with the leads of the program who appeared in the 6 mo of daily videos prescribing the activities the patients were asked to watch and follow. The leads were a prostate cancer oncologist and a scientist in prostate cancer quality of life research. Half of the patients in this study received PC-PEP daily for the first 6 mo and were re-assessed at the end of the year. The other half received standard of care for 6 month and then received the intervention to the end of the year. The results of the study show that, at 6 mo, this intervention was effective at reducing the mental distress that accompanies a prostate cancer diagnosis and treatment compared with the standard of care. Mental distress was significantly reduced when the intervention was received early, compared with that received late (6 mo after scheduled curative treatment). We conclude that multi-faceted patient education and empowerment programming of this kind that is developed with patient engagement from the start is crucial to the care of patients diagnosed with prostate cancer and should be implemented in the standard of care. While treatment for prostate cancer is highly successful, side effects that accompany most treatments significantly affect the quality of life of patients. Here, we describe PC-PEP, a patient education and activation program that is cost effective, highly enforced by patients, and successful at reducing the impact of prostate cancer active treatment-related side effects on their psychological state. To learn more about this project, please visit www.pcpep.org. The program is now being tested in a phase 4 implementation trial throughout Canada and internationally (New Zealand), and is being expanded and tested for other types of cancer.

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