Mailed DNA-based test for colorectal cancer screening

A large trial in US community health centers shows mailed FIT-DNA kits outperform FIT in boosting colorectal cancer screening. Despite this, fewer than 4 in 10 patients with abnormal results complete follow-up colonoscopy. 

Illustration of healthy intestine anatomy on doctor hands.Study: Mailed Outreach for Colorectal Cancer Screening in Community Health Centers. Image credit: Orawan Pattarawimonchai/Shutterstock.com

A fecal immunochemical test-DNA may be a more effective mailed outreach approach than a fecal immunochemical test to increase colorectal cancer screening rates among adults receiving primary care in community health centers, reports a new study published in JAMA Internal Medicine

Colon cancer screening gaps persist in underserved community health centers 

Colorectal cancer (CRC) is the second most common cause of cancer-related deaths in the United States. People living in underprivileged settings are more likely to develop this cancer. Although timely screening can reduce CRC incidence and mortality, it remains underpracticed, particularly in community health centers delivering primary care to at-risk people.

The fecal immunochemical test (FIT) is a widely used, cost-effective screening approach for CRC in community health centers. Emerging evidence indicates a rising trend in the use of mailed FIT outreach approaches to increase its uptake.

FIT-DNA is a newer screening test typically performed every three years, and mailed directly to patients by the manufacturer as part of a structured outreach and support program. For both FIT and FIT-DNA, a follow-up colonoscopy is required if the results are abnormal. Recent evidence indicates that patients who receive mailed FIT outreach are significantly more likely to complete screening than those who do not.

FIT-DNA has higher sensitivity than FIT based on prior evidence and, although typically clinician-ordered, may require less direct involvement from community health center staff due to manufacturer-supported outreach. These factors make FIT-DNA a potentially advantageous approach to improve CRC screening and outcomes.

The current study was designed to compare the effectiveness of mailed FIT and FIT-DNA outreach approaches for increasing CRC screening uptake in community health centers.

Mailed outreach strategies compared with navigation support

The study included eight community health centers located in Greater Boston and Los Angeles. Adults aged 45 to 75 years who were due for CRC screening and received primary care in the included community health centers were eligible for enrollment.

All participants received either a mailed FIT with automated text message outreach from study personnel or a mailed FIT-DNA with the manufacturer’s outreach protocol. Participants with an abnormal FIT or FIT-DNA result were offered standardized navigation support to facilitate completion of colonoscopy.

The primary aim of the study was to assess CRC screening participation within 90 days of either FIT or FIT-DNA. Screening participation within 180 days and the time to screening participation were also assessed.

FIT-DNA outreach significantly boosts screening participation rates

A total of 5127 individuals were enrolled in the study. About 48 % were randomized to the FIT group, and 52 % were randomized to the FIT-DNA group.

The analysis revealed significantly higher screening participation in the FIT-DNA group than in the FIT group at 90 days and 180 days. The time to screening participation was shorter in the FIT-DNA group. Among the two sites, overall screening participation was higher in Boston than in Los Angeles at both time points, although the relative advantage of FIT-DNA over FIT was more pronounced in Los Angeles.

Among 1435 screened participants, 100 had an abnormal test result. Of them, 36 completed a colonoscopy within 180 days.

FIT-DNA outreach may improve screening in underserved populations

The study findings indicate that implementing mailed FIT-DNA outreach in community health centers can significantly increase CRC screening participation and reduce the time to screening participation. However, participation in a colonoscopy following an abnormal screening test result remains suboptimal, regardless of the type of mailed outreach approach.

Several factors could explain the observed increase in screening participation using FIT-DNA. The manufacturer’s patient assistance program offers greater support than mailed FIT outreach with automated reminders, which is the maximal level of support typically achievable in community health centers. Furthermore, a longer screening interval (every three years) and higher test sensitivity may have motivated participants provided with the FIT-DNA option.

Compared to the manufacturer’s average, FIT-DNA completion was lower in this study, potentially due to persistent social and economic barriers to screening for at-risk populations. Clinician’s influence may also play a role here, as FIT-DNA is generally ordered by clinicians after a discussion with the patient.

As observed in the study, overall screening participation was higher in Boston. At the same time, the difference between FIT-DNA and FIT was greater in Los Angeles, suggesting regional variation in response to outreach strategies. This difference may be attributable to variations in patients’ characteristics in these two regions. In Los Angeles, the study participants were largely Hispanic, Spanish-speaking, and uninsured. These factors may partly explain low CRC screening participation in this region.

Taken together, these findings highlight the importance of implementing mailed FIT-DNA outreach to increase CRC screening uptake among individuals who depend on community health centers for primary care. However, the lower colonoscopy completion observed in the study highlights the need for effective strategies to motivate individuals with an abnormal screening test result to undergo a follow-up colonoscopy to improve CRC prognosis.

Community health centers in Boston and Los Angeles used different FIT kit brands, which may have contributed to a higher proportion of abnormal results in Los Angeles community health centers. Given this finding, the researchers recommend considering FIT performance when selecting a FIT kit for routine use, as differences in test performance may influence the number of abnormal results and subsequent need for colonoscopy, rather than definitively indicating higher false-positive rates.

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Journal reference:
Dr. Sanchari Sinha Dutta

Written by

Dr. Sanchari Sinha Dutta

Dr. Sanchari Sinha Dutta is a science communicator who believes in spreading the power of science in every corner of the world. She has a Bachelor of Science (B.Sc.) degree and a Master's of Science (M.Sc.) in biology and human physiology. Following her Master's degree, Sanchari went on to study a Ph.D. in human physiology. She has authored more than 10 original research articles, all of which have been published in world renowned international journals.

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