The FAMKOL trial: Trans-sectoral screening in high-risk populations, comparing nurse-led counselling versus written information materials in first-degree relatives of patients with colorectal cancer.

Abstract

509 Background: Prevention of colorectal cancer (CRC) is a major health care issue. First-degree relatives (FDR) of patients with colorectal cancer have a 2-4-fold increased risk for colorectal cancer. Thus, in this population an adequate participation in the screening colonoscopy is of particular importance. However, appropriate strategies to increase the participation in screening colonoscopy are still lacking. Methods: Cluster-randomized, single blinded, controlled, multicenter trial. At 64 trial sites, 2,411 patients treated for CRC (index patients) were enrolled and n = 1,158 randomized to either paper-based information material only or additional barriers-focused counselling. Index patients were asked to forward trial materials to their FDR. FDR in the intervention group (IG) also received an additional individualized nurse-led counselling on barriers against colonoscopy and were assisted in making appointments to office-based gastroenterologists. Results: N = 313 FDR (IG n = 148; n = 165 controls) aged 28-85 years participated in the trial. A total of 197 FDR underwent preventive colonoscopy (IG n = 99 [66.9%] vs. n = 98 [59.3%]; p >.05). In these 197 patients, polypectomy was performed in n = 69 patients (IG n = 39 [39.4%] vs. n = 30 [30.6%]; p <.05]). Histological examination revealed n = 2 colorectal carcinoma in 197 patients. Conclusions: The FAMKOL trial confirmed the high effectiveness of an interdisciplinary and trans-sectoral invitation to the screening colonoscopy. FAMKOL also verified the significantly higher risk for adenomas and CRC in the targeted patient population. Hence, the permanent implementation of this invitation program may contribute to decrease CRC mortality. Clinical trial information: NCT01903395.