Purpose: Although the provision of a survivorship care plan (SCP) has been recommended after prostate cancer (PCa) treatment, there have been no randomized controlled trials to examine their impact. The objective of this study was to evaluate the effect of a tailored PCa-SCP intervention provided to early-stage PCa survivors.
Materials and methods: A prospective, parallel 1:1 randomized controlled trial was conducted at 3 sites across Canada. Early-stage PCa survivors were randomized (n = 189; 64% response rate) to receive PCa-SCP intervention or usual care. Assessments were performed at baseline, 6 months, and 12 months. The primary outcome was change in patient activation (Patient Activation Measure-13); secondary outcomes included satisfaction with information, self-management support, prostate-specific quality of life, cancer worry, health care utilization, and health behaviors.
Results: For the primary patient activation analyses, no significant group-by-time differences were detected. There were significant between-group differences in (1) satisfaction with information from baseline to 6 months (mean [95% CI]: 7.13 [5.53-8.71]; effect size [ES], 0.34; P < .001) and baseline to 12 months (4.91 [3.06, 7.06], ES, 0.19, P < .001); (2) social integration and support from baseline to 6 months (mean [95% CI]: 0.16 [0.06-0.26]; ES, 0.25; P = .002); and (3) skill and technique acquisition from baseline to 6 months (mean [95% CI]: 0.12 [-0.02 to 0.24]; ES, 0.33; P = .05). No other group-by-time differences were detected.
Conclusions: The PCa-SCP intervention did not have a significant effect on patient activation but did increase satisfaction with information and some aspects of self-management support. Although the benefits of the provision of a SCP alone remain unclear, the PCa-SCP intervention is likely a valuable tool that can be built upon as part of a comprehensive approach to enhance the quality of care for PCa survivors.
Trial registration: clinicaltrials.gov identifier: NCT03017456.
Keywords: prostate cancer; randomized controlled trial; supportive care; survivorship; survivorship care plan.