Abstract 1774P
Background
In a recently published manuscript we demonstrated significant decreases in mental distress, anxiety and depression compared to standard of care following a 6m daily comprehensive program developed with patient engagement. Here we conduct secondary analyses examining the effects of this Prostate Cancer-Patient Empowerment Program (PC-PEP) on patient-reported urinary, bowel, sexual, hormonal and physical function among men scheduled for curative prostate cancer (PC) treatment.
Methods
This crossover randomized clinical trial evaluated 128 men aged 50–82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone), 66 received the 6-mo PC-PEP intervention and 62 were randomized to standard of care for 6m and received PC-PEP to the end of the year. PC-PEP comprises regular physical strength and PFMT training, daily dietary advice, bio-feedback stress reduction, and social networking. Weekly online compliance surveys, the International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite (EPIC), and SF-12 at baseline, 6 and 12m were completed. MLM analyses were used to evaluate the results.
Results
Baseline patient characteristics and outcomes between the two groups were comparable, and weekly compliance for PC-PEP was high among both groups (early v. late intervention). At six months, the PC-PEP group had improved IPSS bother score, EPIC Urinary Incontinence, EPIC Irritative/Obstructive score, physical fitness (lower weight and BMI), SF-12 physical, and mental health function when compared to the control group (p=0.004, p=0.001, p=0.008, p=0.001, p=0.002, and p=0.003 respectively). Analyses revealed that providing the intervention early or late was equally beneficial to patients. No other significant results emerged.
Conclusions
PC-PEP significantly improves lower urinary tract symptoms, physical function and overall quality of life among men scheduled for curative PC treatment compared to standard of care. The program is being currently tested in an international phase 4 trial.
Clinical trial identification
NCT03660085.
Editorial acknowledgement
Legal entity responsible for the study
Nova Scotia Health Authority, Canada.
Funding
Research Nova Scotia Establishment Grant (#2215).
Disclosure
All authors have declared no conflicts of interest.
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