mt-sDNA Test Research Articles

A next-generation mt-sDNA test had 94% sensitivity for colorectal cancer and 91% specificity for advanced neoplasia.

Imperiale TF, Porter K, Zella J, et al; BLUE-C Study Investigators. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med. 2024;390:984-993. 38477986.

Stool-based testing for post-polypectomy colorectal cancer surveillance safely reduces colonoscopies: The MOCCAS study.

Colonoscopy-based surveillance to prevent colorectal cancer (CRC) causes substantial burden for patients and healthcare. Stool tests may help to reduce surveillance colonoscopies, by limiting colonoscopies to individuals at increased risk of AN. This cross-sectional observational study included individuals aged 50-75 with surveillance indication. Before bowel preparation, participants collected samples for a multitarget stool DNA (mt-sDNA) test and two fecal immunochemical tests (FITs). Test accuracies were calculated for all surveillance indications. Only for the post-polypectomy indication, most common and associated with a relatively low CRC risk, long-term impact of stool-based surveillance was evaluated with the ASCCA model. Stool-based strategies were simulated to tune each tests' positivity threshold to obtain strategies at least as effective as colonoscopy surveillance. 3453 individuals had results for all stool tests and colonoscopy. 2226 had previous polypectomy, 1003 previous CRC and 224 familial risk. Areas under the receiver operating characteristic curve for AN were 0.72 (95% CI; 0.69-0.75) for the mt-sDNA test, 0.61 (95% CI; 0.58-0.64) for the FIT OC-Sensor and 0.59 (95% CI; 0.56-0.61) for the FIT FOB-Gold. Stool-based post-polypectomy surveillance strategies at least as effective as colonoscopy surveillance, reduced the number of colonoscopies by 15-41% and required 5.6-9.5 stool tests over the lifetime of a person. Mt-sDNA-based surveillance was more costly than colonoscopy surveillance, whereas FIT-based surveillance saved costs. This study shows that stool-based post-polypectomy surveillance strategies can be safe and cost-effective, with potential to reduce the number of colonoscopies by up to 41%.

Patient-Provider Communication and Colorectal Cancer Screening Completion Using Multi-target Stool DNA Testing.

Colorectal cancer (CRC) screening continues to be underutilized in the USA despite the availability of multiple effective, guideline-recommended screening options. Provider recommendation has been consistently shown to improve screening completion. Understanding how patient-provider communication influences CRC screening can inform interventions to improve screening completion. We developed a behavioral theory-informed survey to identify patient-provider communication factors associated with multi-target stool DNA (mt-sDNA) screening completion. The survey was administered by RTI International between 03/2022 and 06/2022 to a sample of US adults ages 45-75 who received a valid order for mt-sDNA screening with a shipping date between 5/2021 and 9/2021. Respondents completed an electronic or paper survey. Multivariable logistic regression was used to identify patient-provider communication factors associated with mt-sDNA test completion. A total of 2973 participants completed the survey (response rate, 21.7%) and 81.6% of them (n = 2427) reported having had a conversation with provider about mt-sDNA testing before the test was ordered. Having a conversation with the provider about the test, including discussions about costs, the need for follow-up testing and test instructions were associated with higher odds of test completion and being "very likely" to use the test in the future. Lack of discussion about advantages and disadvantages of available CRC screening options and lack of patient involvement in CRC screening decision-making were associated with reduced odds of test completion and likelihood of future use. Healthcare providers play a key role in patient adherence to CRC screening and must be appropriately prepared and resourced to educate and to engage patients in shared decision-making about CRC screening.

Real-world multi-target stool DNA adherence in an underserved and vulnerable prison patient population.

e15632 Background: In 2024, colorectal cancer (CRC) is estimated to be the fourth most diagnosed cancer, as well as the second leading cause of cancer death in the United States. While adherence to regular CRC screening has been suboptimal in the general population, this holds to be especially true in populations that are medically underserved. Non-invasive tests, such as the guideline recommended multi-target stool DNA (mt-sDNA) test, offer a more accessible option to increase screening participation in difficult to reach populations. Herein, we evaluated adherence to CRC screening in a cohort of prisoners who received the mt-sDNA test at a Nebraska Department of Corrections facility in Nebraska. Methods: This was a retrospective cohort study in a small prison population. Participants included both males and females between the ages of 45 and 75 years who underwent CRC screening evaluation at the prison’s medical center between June 1st – December 31st, 2023 and were offered multiple CRC screening options, including the mt-sDNA test. No inducements were provided for completion of the mt-sDNA test. Baseline demographics were collected for cohort description. The primary variable of interest was mt-sDNA test return rate (adherence), defined as completion of the mt-sDNA test within 60 days of kit receipt. We also evaluated mt-sDNA test results in secondary analyses. Results: Once inclusion criteria were applied, the resulting analysis cohort included 129 patients who were first time mt-sDNA screeners. The cohort was largely male (96.9%) and between the ages of 50-64 years (78.3%). Overall mt-sDNA test adherence was 95.3%, with the average time to test completion being 20 days. No significant difference was seen in test completion among males and females (95.2% vs 100%, respectively). Completion rates increased with patient age, at 90.9% (45-49 years), 95% (50-64 years), and 100% (65-75 years). The shortest time to completion in the population was observed amongst patients who were females (18.8 days), and those between the ages of 45-49 years (17.1 days). Negative and positive mt-sDNA test results were observed in 82.9% and 17.1% of the cohort, respectively. Conclusions: CRC screening with the mt-sDNA test in this single-center study of incarcerated participants yielded exceptionally high adherence rates within 60 days of kit receipt. Assessment of follow up colonoscopy rates for test-positive participants is ongoing. While based on a relatively small sample size in this initial study, the mt-sDNA test exhibited favorable completion rates in a difficult to reach population, supporting further efforts to characterize patient, provider, and system-level benefits that may be obtained through broader adoption of this highly accessible screening approach in this challenging healthcare setting.

Real-world multi-target stool DNA longitudinal adherence for colorectal cancer re-screening in a large, national population.

e15633 Background: Colorectal cancer (CRC) is the fourth most diagnosed cancer, as well as the second leading cause of cancer death in the United States – with an estimated 152,810 diagnoses and 53,010 fatal cases in 2024. Regular screening and early detection can reduce CRC incidence and improve overall survival; however, recent national survey data (2021) demonstrate that only 59% of the US screen-eligible population (≥ age 45) is up to date. Home-based, non-invasive CRC screening test options, such as the multi-target stool DNA (mt-sDNA) test, have the potential to improve patient outcomes and overcome CRC screening adherence barriers at multiple levels. Given that the recommended interval for mt-sDNA is three years, a better understanding of use in repeat users is warranted. We evaluated the effective rescreen rate of previous mt-sDNA test users. Methods: In this retrospective cohort study, we included patients between the ages of 45 and 75 years who were shipped an mt-sDNA test kit between January 1st – December 31st, 2023, and had previously completed mt-sDNA screening with a negative result > 2.5 years prior. Our primary variable of interest was mt-sDNA completion rate on repeat testing, defined as kit receipt with a valid result within 120 days of the shipment date. Regression analysis was performed to determine baseline characteristics associated with repeat test completion rate. Results: During the analysis period, a total of 481,748 patients who met the inclusion criteria received an mt-sDNA kit. The majority of the cohort was female (61.4%) and between the ages of 65-75 years (50.9%). Overall repeat test completion rate was 83.6%, with the average time to kit return being 18.9 days. Completion rates were similar between males (83.8%) and females (83.6%), and patients receiving included navigation support via mobile phones demonstrated the shortest average time to kit return (18.7 days). Completion rates increased concordantly with patient age: 81.6%, (45-49 years), 82.2% (50-64 years), and 85% (65-75 years). For first-time rescreen participants (2nd lifetime mt-sDNA test), the completion rate was 83.1%. For second-time rescreen participants (3rd lifetime mt-sDNA test), the completion rate was even higher at 93.6%. Logistic regression analyses revealed that patients re-screening for a second-time were three times more likely to return the mt-sDNA kit for CRC screening (OR = 3.118; p < 0.001). Conclusions: Data from this large, retrospective cohort study revealed that repeat CRC screening with the mt-sDNA test is associated with high adherence to triennial follow-up among participants. suggesting a high-level of perceived patient confidence in repeat performance of the mt-sDNA test. These novel data provide relevant insights regarding strong patient willingness to continue with home-based, non-invasive mt-sDNA testing over multiple cycles of average-risk CRC screening.

Abstract 4787: Preference for multi-target stool DNA for colorectal cancer screening among Alaska Native people in rural/remote communities

Abstract Background: The Alaska Tribal Health System is working on increasing colorectal cancer (CRC) screening rates among Alaska Native people, who have the highest CRC rates in the world. Most remote Alaska Native communities are not connected to the road system, which severely limits access to screening colonoscopy. As part of a clinical trial, Alaska Native patients were offered either colonoscopy or the at-home multi-target stool DNA test (mt-sDNA; Cologuard®). Patients had never been offered mt-sDNA before and it was unknown what they would think about the new test option. Both tests were provided at no cost to patients. Methods: From April 2022 to July 2023, 194 patients who chose mt-sDNA for screening received a follow-up phone survey asking whether they were aware that they could have had colonoscopy instead, their reasons for choosing mt-sDNA, and the factors influencing their choice of mt-sDNA over colonoscopy. Patients answered the survey before receiving results of their mt-sDNA test in order to capture initial screening test preferences. Results: A total of 115 (59%) Alaska Native patients participated in the survey; 56% men and 44% women. About 70% were ages 45 to 60 years while the remaining 30% were 61 to 75 years old. The majority (80%) were aware that they had the option to undergo colonoscopy for CRC screening instead of mt-sDNA. Key themes for mt-sDNA preference included not having to travel, less time commitment, and greater convenience. Many patients expressed financial concerns arising from the costs of air travel and accommodation required to access screening colonoscopy even though the procedure itself was covered. Additionally, patients highlighted existing obligations such as childcare and work responsibilities which made the use of mt-sDNA at home more appealing. Many respondents also shared negative perceptions of colonoscopy procedure including fear, embarrassment, and discomfort as reasons why they preferred mt-sDNA instead. Conclusions: These findings demonstrate the multifaceted factors influencing the preference for at-home mt-sDNA CRC screening among Alaska Native individuals. Challenges such as limited access to medical facilities, financial burdens, and personal commitments have significant bearing on the screening decision-making process. Moreover, the emotional aspect of fear and discomfort associated with colonoscopy plays a role in shaping these preferences. CRC screening programs need to be aware of patient needs and preferences when deciding which screening methods to offer to increase screening rates and result in improved colorectal health outcomes. Citation Format: Diana Redwood. Preference for multi-target stool DNA for colorectal cancer screening among Alaska Native people in rural/remote communities [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4787.

Inappropriate Ordering of Multitarget Stool DNA Tests for Colon Cancer Screening.

CRC screening is recommended for adults aged 45-75. Mt-sDNA is indicated for asymptomatic individuals between the ages of 45 and 85, but not for those with rectal bleeding, iron deficiency anemia, adenomatous polyps, previous colonoscopy within 10 years, family history of CRC, positive results from CRC screening tests within the past 6 months, or age less than 45 and greater than 85. We aimed to determine the prevalence of mt-sDNA use when not indicated and factors associated with inappropriate testing. 7,345 patients underwent mt-sDNA testing and were randomized using EMERSE. Charts for the first 500 patients were reviewed to determine whether mt-sDNA was ordered appropriately according to the USPSTF criteria. Seven patients were excluded due to having more than one inappropriate ordering for mt-sDNA. Of 500 patients, 22.2% had an inappropriately ordered mt-sDNA test. The most common reason for inappropriate ordering was having a previous colonoscopy done within the past 10 years. Rates of inappropriate testing significantly varied by race and the specialty of the ordering provider, with internal medicine providers ordering the most mt-sDNA tests. Rates of inappropriate testing did not significantly vary by sex or type of insurance. Our study suggests that providers may not be familiar with guidelines for the indicated use of mtsDNA, leading to inappropriate referrals and increased costs. Patients at increased CRC risk would benefit from a more sensitive procedure such as a colonoscopy. Future studies could understand the motivation to order testing outside approved indications through provider surveys and interviews.

Next-generation Multi-target Stool DNA Panel Accurately Detects Colorectal Cancer and Advanced Precancerous Lesions.

This study highlights performance of the next-generation mt-sDNA test, which exhibits high sensitivity and specificity for detecting colorectal cancer and APLs. This noninvasive option has potential to increase screening participation and clinical outcomes. A multi-center, clinical validation trial is underway. See related commentary by Bresalier, p. 93.

Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer

Background and AimsThe multitarget stool DNA (mt-sDNA) assay is a non-invasive average-risk colorectal cancer (CRC) screening test. A new biomarker panel was developed for a next-generation test to improve specificity while maintaining/increasing sensitivity. We aimed first to establish an algorithm and cutoff for the next-generation mt-sDNA test and then to validate it using archived samples from the pivotal DeeP-C study (NCT01397747) of the first-generation test. MethodsAlgorithm development and cross-validation included 3011 samples from 2 specimen collection studies (NCT03821948, NCT03789162). The algorithm and cutoff were locked before validation. Validation test set samples included 57 CRC, 583 advanced precancerous lesions (APLs), and 7022 samples negative for CRC or APLs from the DeeP-C study, which prospectively enrolled average-risk, asymptomatic adults aged 50 to 84 years before screening colonoscopy. Next-generation biomarkers included methylated DNA markers LASS4, LRRC4, PPP2R5C, and ZDHHC1 (reference marker), and fecal hemoglobin. Primary validation endpoints were CRC sensitivity and specificity for the absence of advanced neoplasia. Secondary endpoints included APL sensitivity and specificity for non-neoplastic findings or negative colonoscopy. ResultsCross-validation and best-fit results from algorithm development closely matched, confirming algorithm reliability and reproducibility. For the test set, next-generation mt-sDNA test sensitivity was 93.0% (95% CI, 83.0%-98.1%) for CRC and 48.4% (95% CI, 44.2%-52.5%) for APLs. Specificity was 88.5% (95% CI, 87.7%-89.2%) for the absence of advanced neoplasia and 90.4% (95% CI, 89.5%-91.2%) for the combination of non-neoplastic findings or negative colonoscopy. ConclusionsBased on archived samples, the next-generation mt-sDNA test demonstrated promising CRC screening performance characteristics that will be further assessed in a prospective clinical validation study (BLUE-C; NCT04144738).

Provider communication contributes to colorectal cancer screening intention through improving screening outcome expectancies and perceived behavioral control

Colorectal cancer (CRC) screening continues to be underutilized in the US despite the availability of multiple effective, guideline-recommended screening options. Provider recommendation has been consistently shown to improve screening completion. Yet, available literature provides little information as to how specific information providers communicate influence patient decision-making about CRC screening. We tested the pathways through which information communicated by providers about the “Why” and “How” of CRC screening using the mt-sDNA test contributes to intention to complete the test. Data came from a behavioral theory-informed survey that we developed to identify psychosocial factors associated with mt-sDNA screening. RTI International administered the survey between 03/2022-06/2022 to a sample of US adults ages 45–75 who received a valid order for mt-sDNA screening with a shipping date between 5/2021-9/2021. Participants completed an electronic or paper survey. We tested the proposed relationships using structural equation modeling and tested indirect effects using Monte Carlo method. A total of 2,973 participants completed the survey (response rate: 21.7%) and 81.6% (n = 2,427) reported have had a conversation with their health care provider about mt-sDNA screening before the test was ordered. We found that “Why” information from providers was positively associated with perceived effectiveness of mt-sDNA screening, while “How” information was positively associated with perceived ease of use. “Why” information contributed to screening intention through perceived effectiveness while “How” information contributed to screening intention through perceived ease of use. These findings emphasize the critical role of provider communication in shaping patient decision-making regarding CRC screening. CRC screening interventions could consider implementing provider-patient communication strategies focusing on improving patient understanding of the rationale for CRC screening and the effectiveness of available screening options as well as addressing barriers and enhancing patients’ self-efficacy in completing their preferred screening option.

Provider- and System-Level Barriers and Facilitators to Colonoscopy and Multi-Target Stool DNA for Colorectal Cancer Screening in Rural/Remote Alaska Native Communities.

The Alaska Tribal Health System is working to increase colorectal cancer (CRC) screening among Alaska Native people, who experience the highest CRC rates in the world. This study examined CRC screening provider- and system-level barriers and facilitators from the perspective of healthcare providers serving Alaska Native people in rural/remote communities. A total of 28 provider (physicians, advanced practice, and Community Health Aides/Practitioners) interviews were held from 1 February to 30 November 2021. Colonoscopy provider-level barrier themes included time, competing priorities, and staffing, while system-level barriers included travel costs, weather, and the COVID-19 pandemic. Multi-target stool DNA (mt-sDNA) barrier themes included test viability and unfamiliarity, and previous stool tests experiences. For both tests, limited medical record reminders was a major barrier. Facilitator themes for both tests included community outreach, cultural competency and patient navigation, and clinic/system improvements. In-depth interviews with tribal health providers showed that adding mt-sDNA testing may help address system-level colonoscopy barriers such as waitlists and travel costs, but other barriers remain. Further research is needed into patient barriers and facilitators, as well as the effectiveness of integrating mt-sDNA into a geographically dispersed tribal health system to reduce cancer disparities and build equity in CRC prevention among Alaska Native people.

Effects of Academic Detailing, Panel Management and Mailed Multi-Target Stool-DNA Testing on Colorectal Cancer Screening.

Academic detailing, patient-panel management, and mailed, stool-based testing have each been utilized to increase colorectal cancer (CRC) screening in rural clinics. The effectiveness of combining these interventions to increase CRC screening during COVID-19 restrictions was unclear. We explored the effects of a multi-component intervention including academic detailing, active patient panel management, and mailed MT-sDNA testing on colorectal cancer screening in our rural family medicine clinic. Baseline interventions included EMR-based provider alerts and mailed patient reminders. Our intervention (March-May 2020) and follow-up periods (June-August 2020) coincided with the initial COVID-19 surge, giving us the opportunity to observe the effects of our intervention during COVID-19 restrictions. A total of 407 patients were eligible and overdue for colorectal cancer screening. Our clinic's CRC screening rate increased significantly after intervention (69.7%) as compared with before (64.3%) (P = <0.01; 95%CI = 5.39-5.4). Our clinic's CRC screening rates increased significantly during the initial 3 months of the COVID-19 surge (67.8%) compared with the same period the prior year. (62.3%) (P = .003; 95%CI = 3.4-7.6). Our CRC screening rates increased after intervention (69.7%) compared with our regional health system (67%) (P = <0.01; 95%CI = 2.6-2.77). Our weekly stool-based CRC screening increased (94% increase) compared with other health systems nationally (61 to 83% decrease). A multi-component intervention, including academic detailing, panel management, and mailed MT-sDNA testing, can lead to significant increases in CRC screening in a rural family medicine clinic, empowering providers to maintain an effective CRC screening outreach during COVID-19 related restrictions.

S435 Cost-Effectiveness of Mt-sDNA vs Fecal Immunochemical Test for Colorectal Cancer Screening in a Medicare Population

S435 Cost-Effectiveness of Mt-sDNA vs Fecal Immunochemical Test for Colorectal Cancer Screening in a Medicare Population

Noninvasive colorectal cancer screening techniques: literature review

Fecal DNA testing is a noninvasive method recommended by professional medical societies for colorectal cancer screening in individuals with intermediate risk of the disease. Adenamatous and serrated lesions, as well as cancer, lead to exfoliation of cells containing neoplastic altered DNA which, in turn, can be detected with sensitive testing methods aimed at specific genetic and epigenetic biomarkers. Mt-sDNA test approved by the United States Food and Drug Administration in 2014 showed sensitivity of 92 % for detection of colorectal cancer which is much higher than sensitivity of fecal immunochemical test (74 %).

Neoplasia Diagnosis After Multi-target Stool DNA Is Enhanced Among Lowest Baseline Detectors.

Variation in colorectal neoplasia detection limits the effectiveness of screening colonoscopy. By evaluating neoplasia detection rates of individual colonoscopists, we aimed to quantify the effects of pre-procedural knowledge of a positive (+) multi-target stool DNA (mt-sDNA) on colonoscopy quality metrics. We retrospectively identified physicians who performed a high volume of + mt-sDNA colonoscopies; colorectal neoplasia at post-mt-sDNA colonoscopy was recorded. These colonoscopists were stratified into quartiles based on baseline adenoma detection rates. Baseline colonoscopy adenoma detection rates and sessile serrated lesion detection rates were compared to post-mt-sDNA colonoscopy neoplasia diagnosis rates among each quartile. Withdrawal times were measured from negative exams. During the study period (2014-17) the highest quartile of physicians by volume of post-mt-sDNA colonoscopies were evaluated. Among thirty-five gastroenterologists, their median screening colonoscopy adenoma detection rate was 32% (IQR, 28-39%) and serrated lesion detection rate was 13% (8-15%). After + mt-sDNA, adenoma diagnosis increased to 47% (36-56%) and serrated lesion diagnosis increased to 31% (17-42%) (both p < 0.0001). Median withdrawal time increased from 10 (7-13) to 12 (10-17) minutes (p < 0.0001) and was proportionate across quartiles. After + mt-sDNA, lower baseline detectors had disproportionately higher rates of adenoma diagnosis in female versus male patients (p = 0.048) and higher serrated neoplasia diagnosis rates among all patients (p = 0.0092). Knowledge of + mt-sDNA enriches neoplasia diagnosis compared to average risk screening exams. Adenomatous and serrated lesion diagnosis was magnified among those with lower adenoma detection rates. Awareness of the mt-sDNA result may increase physician attention during colonoscopy. Pre-procedure knowledge of a positive mt-sDNA test improves neoplasia diagnosis rates among colonoscopists with lower baseline adenoma detection rates, independent of withdrawal time.

Inappropriate Multi-Target Stool DNA Use for Colorectal Cancer Screening: Risks, Compliance, and Outcomes.

Background Inappropriate or "off-label" use of multi-target stool DNA (mt-sDNA) tests refers to their use in patients for whom colonoscopy or no testing at all is warranted. Examples include a positive family history of colorectal cancer, a history of inflammatory bowel disease, or medical issues necessitating diagnostic colonoscopy, among others. Current understanding of off-label mt-sDNA use for colorectal cancer screening, its associated risks, and outcomes is lacking. We examined off-label mt-sDNA prescription and compliance with testing in an outpatient setting in southeast Michigan. Aims The primary aims of the study were determining the extent of off-label mt-sDNA testing and compliance, and results of all testing, as well as demographic factors associated with off-label prescriptions. The secondary aims were to examine explanations for incomplete testing and factors contributing to successful completion. Methods Using a retrospective design, we identified mt-sDNA orders from outpatient internal medicine clinics between January 1, 2018, to July 31, 2019, to evaluate the proportion of off-label mt-sDNA, results of testing, and follow-up colonoscopies up to one year after order placement. Patients were categorized as "off-label" if any inappropriate criteria were met. Statistical analysis was performed for primary and secondary outcomes. Results From 679 mt-sDNA orders within the study period, 81 (12.1%) had at least one off-label criterion for testing. In total, 404/679 (59.5%) patients completed testing. Lack of follow-up comprised the majority of incompletions (216/275; 78.6%). Only 52 (70.3%) out of 74 positive results were followed by diagnostic colonoscopy. Retired employment status (OR = 1.87; 95%CI, 1.17-2.98; P = 0.008) and age of 76 years or older (OR = 2.28; 95%CI, 0.99-5.21; P = 0.044) were significantly associated with increased risk of off-label mt-sDNA prescription. Increasing age range was associated with higher test completion (χ2 (5) = 12.085, p = 0.034). Multinomial logistic regression revealed an increasing age range (OR = 1.29; 95% CI, 1.09-1.54; P = 0.004), predictive of a positive mt-sDNA result for both groups. There was no significant difference between off-label or on-label groups in the mean number of resected polyps or pathology scores on follow-up colonoscopy. Conclusions Off-label mt-sDNA use remains a concern in the outpatient setting. Compliance for test completion and follow-up colonoscopy for positive results require further improvement. Our findings shed new light on the factors associated with off-label testing while reiterating its burden. We also describe common reasons for incomplete tests in an attempt to augment future colorectal cancer (CRC) screening initiatives.

Patient-provider communication factors associated with mt-sDNA screening for colorectal cancer.

e22514 Background: Several colorectal cancer (CRC) screening tests, shown to reduce CRC incidence and mortality, are recommended for average-risk adults aged 45-75 years. CRC screening is underutilized in the US with access to facility-based options, such as colonoscopy, representing a barrier to screening. Stool-based tests are guideline-endorsed and offer patients a convenient and more accessible CRC screening option that can be completed at home. Provider recommendation is consistently identified as the primary factor driving patient adherence. Understanding how aspects of patient-provider communication influence CRC screening can inform interventions to improve adherence. We developed a survey, informed by behavioral theory, to identify communication factors associated with completion of mt-sDNA screening. Methods: Adults aged 45-75 years, with a US postal address, who received a valid order for mt-sDNA and whose kit was shipped between 5/21-9/21 were eligible for sampling. The survey was administered by RTI International between 3/22-6/22. Participants could complete electronic or paper surveys. We fit a multivariable logistic regression to identify patient-provider communication factors associated with mt-sDNA test completion. Results: 2,973 respondents completed the survey (response rate = 21.7%). The majority (77.3%) completed the mt-sDNA test and said they would be ‘very likely’ (76.8%) to complete Cologuard in the future. The proportion of respondents who had conversations with their healthcare provider about Cologuard, and the specific content of those conversations, was significantly different between completers and non-completers and between respondents who said they were ‘very likely’ to complete Cologuard in the future compared to respondents who were not. Results from a binary logistic regression suggested that discussions with a healthcare provider related to step-by-step instructions for completing Cologuard (OR = 1.62) and needing to have a colonoscopy follow-up (OR = 1.93), as well as feeling included ‘a great deal’ in the decision-process with respondents’ healthcare provider (compared to ‘somewhat’ or ‘not at all’) increase the odds of kit completion. Additionally, healthcare provider discussions relating to test cost (OR = 1.47) and performance (OR = 1.72), as well as feeling included ‘a great deal’ in the decision-process was positively associated with respondents indicating they were ‘very likely’ to use Cologuard in the future. Provider discussions about the cost of a follow-up colonoscopy was negatively associated with a ‘very likely’ future user (OR = 0.52). Conclusions: Healthcare providers play a key role in patient adherence to CRC screening and must be appropriately prepared and resourced to educate and to engage patients in shared decision-making about CRC screening.

Association of awareness and use of patient navigation services for colorectal cancer screening with test completion and likelihood of future use.

61 Background: Although several guideline-recommended colorectal cancer (CRC) screening modalities have been shown to reduce CRC incidence and mortality, adherence remains below U.S. public health goals. Patient navigation services have been shown to improve CRC screening completion. Patient navigation services, including outbound phone, text, and e-mail reminders, and inbound phone support (&gt;200 languages) are included with all mt-sDNA test (Cologuard) orders. A website and financial assistance (upon request and qualification) are also available for patients. We developed a survey, informed by behavioral theory, to identify psychosocial and communication factors associated with completion of mt-sDNA screening including questions to evaluate awareness and use of navigation services. Methods: Adults aged 45-75 years, with a US postal address, who received a valid order for mt-sDNA screening between 5/21-9/21 were eligible for sampling. RTI administered the survey between 3/22-6/22. Participants had the option to complete electronic- or paper-based surveys. We conducted crosstabulation with Chi Square to assess whether awareness and use of navigation services was significantly associated with (a) test completion within 6 months of the order date and (b) likelihood of future mt-sDNA use. Results: 2,973 participants completed the survey (RR= 21.7%; 65.15% by web and 34.85% by paper). Responders and non-responders did not differ significantly by age or sex. For each navigation service, awareness was significantly higher among those who completed the mt-sDNA test compared to those did not. Across all services, awareness was significantly higher among respondents reporting they were ‘very likely’ to complete mt-sDNA if recommended by a healthcare provider in the future than all other responses combined. A significantly higher proportion of completers (vs. non-completers) reported receiving the email reminder, using the Cologuard website, and using the English language inbound phone support. A significantly higher proportion of those “very likely” to complete mt-sDNA screening in the future reported receiving the email reminder, using the Cologuard website, and using the English language inbound phone support. Conclusions: Awareness and use of patient navigation services was associated with higher completion of the mt-sDNA test and with greater likelihood of future mt-sDNA test use. Patient navigation services comprised of evidence-based strategies, such as reminders, support patient adherence to CRC screening.

Psychosocial, behavioral, and communication factors associated with completion of the mt-sDNA test for colorectal cancer screening.

60 Background: Colorectal cancer (CRC) screening has been shown to reduce CRC incidence and mortality. Several CRC screening modalities are guideline recommended for average-risk adults aged 45-75 years. CRC screening is underutilized in the US and access to facility-based options, such as colonoscopy, represents a potential barrier. Home-based stool tests are guideline-endorsed and offer a convenient, accessible, scalable option for CRC screening. Thus, understanding the factors that influence completion of stool-based CRC screening is important to guide interventions to improve adherence. We developed a survey, informed by behavioral theory, to identify psychosocial, behavioral and communication factors associated with completion of mt-sDNA screening. Methods: The survey instrument was finalized through expert review, quality testing, and cognitive testing. Adults aged 45-75 years, with a US postal address, who received a valid order for mt-sDNA and whose kit was shipped between 5/21-9/21 were eligible for sampling. RTI administered the survey between 3/22-6/22. Participants had the option to complete electronic or paper surveys. We fit a multivariable logistic regression to identify factors significantly associated with mt-sDNA test completion. Results: Of 17,370 individuals invited to participate, 2,973 completed the survey (AAPOR RR3 = 21.7%); 77.3% of the sample completed the mt-sDNA test. Responders and non-responders did not differ significantly by sex or age. Controlling for demographic characteristics and insurance status, the odds of mt-sDNA test completion were significantly higher among participants who reported greater perceived test effectiveness (OR = 1.20), greater ease (OR = 4.06), and greater comfort in test use (OR = 1.18). Odds of test completion were significantly higher among participants who reported their healthcare provider discussed the mt-sDNA test with them (OR = 2.01) and involved them a great deal in decision making about CRC screening (OR = 1.29). Participants who expressed greater worry about developing CRC were less likely to return their mt-sDNA kit (OR = 0.81). Conclusions: To improve population adherence to CRC screening recommendations, efforts are needed to ensure patients understand the attributes and effectiveness of available test options and feel adequately prepared to complete their preferred screening test. Additionally, healthcare providers must be appropriately prepared and resourced to educate and to engage patients in shared decision-making about CRC screening.

Diagnostic accuracy of the multi-target stool DNA test in detecting colorectal cancer: A hospital-based study.

The multi-target stool DNA test (MT-sDNA) has potential utility in the detection of colorectal cancer (CRC), but validation of its clinical accuracy has been limited in China. To evaluate the diagnostic performance of MT-sDNA and investigate the combined diagnostic value of alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and carbohydrate antigen 199 (CA199) with MT-sDNA in CRC and adenomas. We evaluated the performance of the MT-sDNA kit based on a hospital clinical trial. In this case-control study, 135 participants from the Affiliated Hospital of Medical School of Ningbo University, including 51 CRC patients, 23 patients with adenomas, and 61 healthy controls were enrolled. We used a risk scoring system to determine the positivity of tests with histological diagnosis or colonoscopy as the reference standard. The main indices of sensitivity, specificity and accuracy were evaluated. The sensitivity and specificity for CRC detection were 90.2% and 83.3%, respectively, with an accuracy of 89.8%. For adenoma, the sensitivity and specificity were 56.5% and 68.9%, respectively, with an accuracy of 73.1%. The sensitivity and specificity of MT-sDNA combined with CEA in the diagnosis of adenoma were 78.3% and 60.7%, respectively. The MT-sDNA test showed better performance in the detection of CRC, which was superior to AFP, CEA, and CA199 separately, but not for predicting adenomas. The combination of MT-sDNA with CEA further improved the sensitivity for adenoma diagnosis.