Increasing colorectal cancer screening among Alaska Native peoples living in remote areas of Alaska: a multitarget stool DNA cluster randomized controlled trial.

Abstract

Increased colorectal cancer (CRC) screening is needed to address high Alaska Native (AN) CRC rates. The study objective was to evaluate high-intensity vs. medium-intensity patient outreach using multi-target stool DNA (mt-sDNA) or colonoscopy. A community-level, cluster-randomized clinical trial (April 29, 2021, through September 15, 2024) in 46 rural/remote Alaska communities. Participants were asymptomatic AN adults aged 45-75 with no family or personal history of CRC who were due for screening. High-intensity: Up to six patient navigator telephone calls with follow-up mailer. Medium-intensity: Mailed letter with one follow-up call. Usual care: Standard of care clinical visits. The primary outcome was screening completion within 12 months. Secondary outcomes included test preference, abnormal mt-sDNA follow-up colonoscopy, and colonoscopy outcomes. A total of 2029 AN people (mean [SD] age, 56 [8.4] years; 816 women [40%]) were randomized including 587 to usual care, 696 to medium-intensity, and 746 to the high-intensity arm. Both men and women were significantly more likely to request mt-sDNA (70%) over colonoscopy (30%, p < 0.01), with participants ≥ 65 years old most likely to request mt-sDNA. Screening completion within 12 months among the total population was significantly higher in the medium-intensity (24%) and high-intensity arms (28%) compared with usual care (6%) (p<0.01). Compared to usual care, CRC screening odds were higher with high-intensity (odds ratio [OR], 5.90; 95% CI, 3.86-9.04) and medium-intensity intervention (OR, 4.87; 95% CI, 3.18-7.46). Among those who agreed to screen, completion was similar in both intervention arms. Screening completion was 16% higher among high-intensity vs. medium-intensity participants (OR, 1.25; 95% CI, 0.91-1.71, p=0.19). Of the total eligible population, 254/2029 people (12.5%) had valid mt-sDNA tests and 278/2029 (13.7%) had complete colonoscopies. CRC/advanced neoplasia was found in over 25% of initial screening colonoscopies and 59% of colonoscopies performed after abnormal mt-sDNA. Both a medium- and a high-intensity intervention were significantly more effective at increasing screening initiation and completion rates compared with usual care in rural/remote Alaskan communities. Participants significantly preferred mt-sDNA for screening. These findings highlight the clinical utility of focused outreach strategies in primary care settings and support the use of mt-sDNA as a viable alternative to colonoscopy in geographically isolated populations. The study is registered with the Clinical Trials Registry (Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People, NCT04336397, https//www.cancer.gov/research/participate/clinicaltrialssearch/v? id=NCI202108691, registration date 04/03/2020) and was designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement.