Abstract Background 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. Methods 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. Results 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. Conclusions 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. Trial registration 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.
Redwood et al. (Tue,) studied this question.
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