General practitioner-led vs surgeon-led colon cancer survivorship care: A randomized clinical trial.

1513 Background: The role of general practitioners (GPs) in providing survivorship care for cancer patients remains debated. In 2015, the randomized I CARE trial was initiated to evaluate the impact of GP-led vs. surgeon-led survivorship care on quality of life (QoL) and assess the effect of the eHealth application Oncokompas. An interim analysis after 12 months revealed no clinically relevant differences in QoL changes. However, patients continued to have follow-up consultations for up to 60 months after treatment. This study addressed the long-term QoL outcomes of the trial. Methods: The I CARE trial was a pragmatic, 2x2 factorial, open-label, randomized controlled trial. The trial was conducted in 8 hospitals and 225 general practices across the Netherlands. The trial included patients who underwent primary surgical treatment for stage I-III colon cancer or rectosigmoid carcinoma, and who were eligible for routine follow-up according to national guidelines. Inclusion lasted from March 26, 2015, to Nov 21, 2018. Patients were randomized using variable block randomization, stratified by age and tumor stage, into four groups (1:1:1:1): usual surgeon-led care, surgeon-led care with Oncokompas, GP-led care, and GP-led care with Oncokompas. The primary outcome was QoL at 5 years, as measured by the change from baseline in the EORTC QLQ-C30 summary score (range 0-100). Generic and disease-specific QoL were measured at baseline, 3, 6, and 12 months, and annually up to 60 months post-treatment. Differences in QoL changes were analyzed using piecewise linear mixed-effects models with a knot at 24 months to capture potential deviations in QoL recovery. A 10-point difference was considered clinically relevant (superiority design with α = 0.05, power of 80%, and 15% dropout). The trial is registered with the Netherlands Trial Register (NTR4860). Results: In total 303 patients were enrolled; 79 were randomized to surgeon-led care, 83 to surgeon-led care with Oncokompas, 73 to GP-led care, and 68 to GP-led care with Oncokompas. Patients were male (67%) with a mean age of 68.0 years (SD 8.4). Of the 151 patients assigned to Oncokompas, 51 (36%) reported using the app at least once in the first year. Baseline QoL was high in all groups. No clinically meaningful differences in QoL were observed between GP-led and surgeon-led groups at 24 months (difference of -0.5 [95% CI -1.6 to 0.5]) and 60 months (-0.01 [-0.8 to 0.8]). Oncokompas also had no meaningful effect (difference of 0.8 [0.0 to 1.6] at 60 months). Conclusions: In this pragmatic, randomized controlled trial conducted in the Netherlands, GP-led survivorship care did not improve long-term QoL compared to traditional surgeon-led care among non-metastatic colorectal cancer survivors. Due to low usage rates, the impact of Oncokompas is inconclusive. Survivorship care models can be tailored to fit individual preferences. Clinical trial information: NTR4860 .