1774P - PC-PEP, a comprehensive daily six-month home-based prostate cancer: Patient empowerment program improves quality of life, physical fitness, and urinary function outcomes among prostate cancer patients with localized disease - Secondary analyses of a randomized clinical trial

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.