The ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer.
There is a growing prevalence of prostate cancer survivors. Men with prostate cancer require long term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. International policy recognises the growing role of primary care in cancer survivorship but there have been no trials testing new models of shared care in prostate cancer.
Men who had completed surgery and/or radiotherapy for low to moderate risk prostate cancer within the previous eight weeks were eligible. Participants were randomised to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and health care resource use.
Eighty-eight men were randomised (Shared Care n=45; Usual Care n=43). There were no clinically important or statistically significant differences between groups on distress, prostate cancer-specific quality of life, or satisfaction with care. Preferences for follow-up care models differed between groups (p=0.0007), with a shared care model being preferred by 63% of intervention patients compared to 24% of controls after 12 months. There was high compliance with PSA monitoring in both groups. The shared care model was cheaper than usual care (Shared care AUS$1,411; Usual Care AUS$1,728; difference AUS$323 (plausible range AUS$91-554)).
Well-structured shared care for men with low to moderate risk prostate cancer is feasible and appears to produce clinically comparable outcomes to standard care at lower cost. A larger phase III trial powered to demonstrate equivalence in clinical endpoints would not be feasible. This trial could inform implementation of such a model into routine clinical care.