Protocol for a pragmatic trial comparing navigator and automated virtual interventions for guaranteeing adherence to fecal immunochemical testing (NAVIGATE-FIT).

Approximately 60 million adults live in rural regions of the US, which historically have low rates of colorectal cancer (CRC) screening and follow-up. Rural residents enrolled in Medicaid have particularly low CRC screening and follow-up rates. To determine the effectiveness and implementation of a collaborative Medicaid health plan-clinic program of mailed fecal immunochemical test (FIT) outreach and patient navigation to colonoscopy following an abnormal FIT result when implemented in rural clinics as part of standard care. This cluster randomized clinical trial was conducted at 28 rural clinic units in Oregon affiliated with 3 Medicaid health plans. The clinics were randomized to the intervention (n = 14) or to usual care (n = 14). Participants were Medicaid enrollees (aged 50-75 years) due for CRC screening. The intervention was delivered from May 11, 2021, through June 4, 2022, and analyses were performed from June 2023 through September 2024. The stepwise intervention involved (1) mailed FIT outreach and (2) patient navigation to colonoscopy following an abnormal FIT result. Implementation support included practice facilitation, training, collaborative learning, and patient tracking tools. The primary effectiveness outcome was completion of any CRC screening within 6 months of eligibility determination. An additional effectiveness outcome was follow-up colonoscopy completion within 6 months of an abnormal FIT result. Implementation was measured as (1) the proportion of intervention-eligible enrollees who were mailed an FIT and who were sent an advance notification or reminder and (2) the proportion with an abnormal FIT result who were offered patient navigation. This study included 5614 Medicaid enrollees (2613 in intervention clinics and 3001 in usual care clinics). Enrollees had a mean (SD) age of 58.2 (5.5) years; most (4940 [88.0%]) were aged 50 to 64 years. A total of 2948 enrollees (52.5%) were female, 325 (6.2%) were Hispanic and 3774 (67.2%) were White, and 4457 (79.4%) lived in rural regions. Compared with Medicaid enrollees in usual care clinics, enrollees in intervention clinics had a higher adjusted 6-month proportion of any CRC screening completion (11.8% vs 4.5%; difference, 7.3 [95% CI, 5.3-9.2] percentage points). Implementation was 100% (all 1489 intervention-eligible enrollees) for mailed FIT outreach, 88.5% for advance notification, 78.1% for reminders, and 57.9% for patient navigation. In this cluster randomized clinical trial of rural clinics, mailed FIT outreach and patient navigation boosted participation in CRC screening among Medicaid enrollees. More efforts are needed to address low participation in both FIT testing and follow-up colonoscopy. ClinicalTrials.gov Identifier: NCT04890054.

Noninvasive colorectal cancer (CRC) screening bears high potential for increasing participation if implemented in a straightforward way. We have evaluated the feasibility and diagnostic performance of a smartphone-based fecal immunochemical test (FIT) for CRC screening and compared its performance with a laboratory-based FIT. Individuals scheduled for a screening colonoscopy in gastroenterology practices in Southern Germany enrolled into the BLITZ study between 2021 and 2023 were offered a smartphone-based FIT and a laboratory FIT. The smartphone-based FIT consists of a rapid test and a smartphone app. The app quantitatively evaluates the result of the rapid test using the smartphone camera. The feasibility of the smartphone-based FIT was evaluated in a self-administered questionnaire. The comparative performance of the 2 FITs was evaluated by sensitivity, specificity, and receiver-operator curve (ROC) measures. Of 654 study participants who were offered both a smartphone-based FIT in addition to the laboratory FIT, 361 (55%) made use of the smartphone-based FIT, 274 (76%) of those had a valid smartphone-based FIT, and 643 (98%) used the laboratory FIT. Overall, 89% considered the smartphone-based FIT as a useful alternative offer to the laboratory FIT. The reasons why the smartphone-based FIT was not used were mostly technical (app- or smartphone-related, 47%) or reflecting more general concerns or attitudes towards such a test (44%). The smartphone-based FIT showed a sensitivity for advanced neoplasms (28%; 95% confidence interval [CI], 13%-47%) similar to the laboratory FIT (34%; 95% CI, 18%-54%) at an identical specificity (92%; 95% CI, 87%-95%). The smartphone-based FIT could serve as an alternative in addition to currently offered laboratory FITs. German Clinical Trials Register (drks.de), Number: DRKS00008737.

To the Editor: Fecal immunochemical tests (FITs) are immunoassays that are designed to detect human hemoglobin to indicate the occurrence of colonic neoplasia, which have been widely used in global colorectal cancer (CRC) screening programs. Previous diagnostic studies demonstrated that strong gradient in site-specific sensitivity existed with typically higher rate for advanced adenoma located in distal colon/rectum than that in the proximal parts, which may be explained by the colonic transition time affecting the degradation of hemoglobin, and the shape of adenoma (pedunculated, flat, and sessile) in different anatomic regions.[1] In addition, questionnaire-based risk assessment (QRA) using the established CRC-related risk factors has been proposed to identify high-risk populations for CRC screening.[2] However, previous studies demonstrated that site-specific differences existed for several risk factors.[3,4] In a CRC screening setting, whether and to what extent the FIT and QRA would affect the site-specific detection rate of colorectal neoplasia have not been evaluated. Therefore, we aimed to empirically evaluate the site-specific variations of the detection rates of adenomas for the FIT- and QRA-based screening based on a population-based CRC screening trial (TARGET-C). The study was conducted in the context of an ongoing TARGET-C trial consisted of 19,546 participants, aiming to evaluate the effectiveness of colonoscopy, FIT, and risk-adapted screening approaches in CRC screening in China, and the detailed study protocol has been previously published.[5,6] For the present study, we included 3825 subjects aged 40 to 74 years undertaking colonoscopy in the baseline screening in 2018–2019, of which 1665 were for screening purpose (colonoscopy arm), 1436 were for diagnostic purpose following positive-FIT (FIT arm or risk-adapted screening arm), and 724 were for diagnostic purpose following positive-QRA (risk-adapted screening arm). This study was approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College (No. 18-013/1615). All participants provided written informed consent. For the QRA use in the present study, the modified Asian-Pacific colorectal screening (APCS) score was used for risk stratification, including five risk factors of CRC (age, sex, family history of CRC among first-degree relatives, smoking, and body mass index [BMI]). Each factor is allocated a score, as followed described: age (0 point: 50–54 years; 1 point: 55–65 years; 2 points: 65–74 years); sex (0 point: female; 1 point: male); family history of CRC among first-degree relatives (0 point: absent; 1 point: present); smoking (0 point: non-smoker; 1 point: current or past smoker); and BMI (0 point: <23; 1 point: ≥23). The cumulative score was calculated. Subjects with scores ≥4 were defined as high-risk and were referred for colonoscopy; those with scores <4 were defined as low-risk and were referred for FIT screening. A self-administered qualitative FIT for hemoglobin (Pupu Tube, New Horizon Health Technology, Hangzhou, China) was used in this trial. The FIT enabled visual interpretation of the test results as positive or negative by eye if the fecal hemoglobin concentration exceeded the threshold specified by the manufacturer (100 ng Hb/mL, equivalent to 4 μg Hb/g feces). Participants with confirmed positive-FIT results were scheduled for subsequent diagnostic colonoscopy. Additional information regarding the study design is provided in the Supplementary File, https://links.lww.com/CM9/A447. The primary outcome of interest was the detection rate for advanced adenoma or non-advanced adenoma, which was calculated by numbers of the carriers with disease divided by the total number included participants. Advanced adenoma was defined as high-grade dysplasia, villous or tubular-villous histologic features, measuring 1 cm or more in diameter. Regarding the location of the neoplasm, the proximal colon was considered to include the splenic flexure and all segments proximal to it, and the rest was considered distal colon/rectum. For subjects having multiple adenomas, the outcome and anatomic location were defined according to the most advanced one. Site-specific detection rate was therefore calculated and compared between the three groups of subjects undertaking colonoscopy, that is, screening purpose, diagnostic purpose either of positive-FIT or positive-QRA. For the 3825 included subjects, the mean (standard deviation) age was 60.5 (6.3) years and slightly more men (n = 1977, 51.7%) were included. Overall, among the subjects undertaking screening colonoscopy and diagnostic colonoscopy after positive-FIT, no significant differences regarding the distribution of sociodemographic factors were observed. For subjects undertaking diagnostic colonoscopy after positive-QRA, the distribution of these factors was significantly different than the other two groups, because factors of age, sex, BMI, cigarette smoking, and history of CRC among the first-degree relatives were included in the risk assessment [Supplementary Table 1, https://links.lww.com/CM9/A447]. For subjects undertaking screening colonoscopy, the detection rates of advanced adenoma located in the distal colon/rectum and proximal colon were 3.12% (95% CI: 2.39–4.07%) and 2.52% (95% CI: 1.87–3.39%), the rate ratio distal vs. proximal was 1.24 (95% CI: 0.83–1.85), and the rate difference distal vs. proximal was 0.60% (95% CI: −0.52 to 1.73%). As expected, the detection rates of advanced adenoma increased for subjects with either positive-FIT (proximal vs. distal: 8.64% [95% CI: 7.29–10.20%] vs. 3.90% [95% CI: 3.01–5.03%]) or positive-QRA (proximal vs. distal: 6.91% [95% CI: 5.28–8.99%] vs. 4.70% [95% CI: 3.38–6.49%]), however, the rate ratiodistal vs. proximal increased to 2.21 (95% CI: 1.63–3.00; PFIT vs. colonoscopy = 0.025) and 1.47 (0.96–2.24; PQRA vs. colonoscopy = 0.567), respectively; and the rate differencedistal vs. proximal increased to 4.74% and 2.21%, respectively. Regarding detection for non-advanced adenoma and any adenoma, there were no significant differences in detection rates among the subjects of either positive-FIT or positive-QRA compared with the subjects undertaking screening colonoscopy. Detailed results are shown in Table 1. Table 1 - Differences in detection rate of colorectal adenoma among subjects performing colonoscopy with different indications (n=3825) Outcome Site Detected cases (n) Detection rate (%, 95%CI) Rate ratio P value ∗ Rate difference (%, 95% CI) Advanced adenoma Colonoscopy (n = 1665) Distal 52 3.12 (2.39–4.07) 1.24 (0.83–1.85) Reference 0.60 (–0.52–1.73) Proximal 42 2.52 (1.87–3.39) Reference Reference FIT (n = 1436) Distal 124 8.64 (7.29–10.20) 2.21 (1.63–3.00) 0.025 4.74 (2.97–6.50) Proximal 56 3.90 (3.01–5.03) Reference Reference QRA (n = 724) Distal 50 6.91 (5.28–8.99) 1.47 (0.96–2.24) 0.567 2.21 (–0.20–4.62) Proximal 34 4.70 (3.38-6.49) Reference Reference Non-advanced adenoma Colonoscopy (n = 1665) Distal 207 12.43 (10.93–14.10) 1.35 (1.11–1.64) Reference 3.24 (1.14–5.35) Proximal 153 9.19 (7.89–10.67) Reference Reference FIT (n = 1436) Distal 228 15.88 (14.08–17.86) 1.37 (1.14–1.65) 0.915 4.32 (1.81–6.83) Proximal 166 11.56 (10.00–13.32) Reference Reference QRA (n = 724) Distal 105 14.50 (12.13–17.26) 1.21 (0.93–1.58) 0.514 2.49 (–1.01–5.98) Proximal 87 12.02 (9.85–14.59) Reference Reference Any adenoma Colonoscopy (n = 1665) Distal 259 15.56 (13.89–17.38) 1.33 (1.12–1.58) Reference 3.84 (1.52–6.17) Proximal 195 11.71 (10.25–13.35) Reference Reference FIT (n = 1436) Distal 352 24.51 (22.36–26.80) 1.59 (1.37–1.85) 0.125 9.05 (6.15–11.96) Proximal 222 15.46 (13.68–17.42) Reference Reference QRA (n = 724) Distal 155 21.41 (18.58–24.54) 1.28 (1.03–1.59) 0.786 4.70 (0.66–8.74) Proximal 121 16.71 (14.17–19.60) Reference Reference FIT: Fecal immunochemical test; QRA: Questionnaire-based risk assessment. ∗P values were calculated comparing the differences of rate ratios between the examined group and the colonoscopy group using the Z-test proposed by Douglas G Altman and J Matrtin Bland (BMJ 2003;326: 219). In this retrospective analysis based on a population-based CRC screening trial, by setting the yield of screening colonoscopy as a reference reflecting the real-world prevalence of adenoma in different anatomic locations, we found that FIT- and QRA-based screening had large variations in terms of detection rates for proximal and distal located advanced adenoma, although the difference was only statistically significant for the FIT-based approach. There were several reasons that might explain the variations of the detection rates for advanced neoplasia located in the proximal and distal colon/rectum. First, most of the distal adenomas are pedunculated, which may therefore be more prone to be bleeding than the flat and sessile adenomas that are more likely to be detected in the proximal colon. Second, the degradation time for fecal hemoglobin is longer for proximal lesions than distal ones, which may therefore lead to the variation of the detection rate, although data to support this are sparse. Previous studies have suggested that lowering the positivity threshold of FIT may help to increase the sensitivity for detecting proximal neoplasm. The positivity threshold of FIT used in the present study was 4 μg Hb/g feces, which was lower than other FIT-based CRC screening programs.[8] Based on our results, such a strategy of lowering the positivity threshold of FIT may not aid such an issue. Another important finding of our study was that QRA also lead to divergent detection rates for proximal and distal neoplasms, although the differences were not statistically significant. Although the reasons behind this cannot be fully understood, we inferred that a series of factors such as smoking and BMI had different magnitudes of attributable risk in proximal and distal CRC, as demonstrated in a recently published study.[3,4] Further attention should be paid to this issue, since combining environmental and polygenic factors has been suggested in tailored risk-adapted CRC screening. Our study has limitations. First, the analysis was derived from a single round of screening, however, the current finding indicated that the differences between the detection rate for proximal and distal advanced adenoma may be even larger over multiple rounds of screening. Second, despite the overall large sample size of the trial, numbers of the advanced adenomas were still rather limited leading to rather wide confidence intervals, which should be addressed in further larger studies.[7] To sum up, we empirically demonstrated the divergent detection rates of proximal and distal advanced adenomas existed in FIT-based but not in the QRA-based CRC screening. Further efforts should be made to optimize the effectiveness of CRC screening by improving the lower detection rate of proximal advanced adenomas. Funding This work was supported by grants from the CAMS Innovation Fund for Medical Sciences (No. 2017-I2M-1-006), the National Natural Science Foundation of China (No. 81703309), Beijing Nova Program of Science and Technology (No. Z191100001119065), and the Natural Science Foundation of Beijing Municipality (No. 7202169). Conflicts of interest None.

Colon Cancer Screening Models: Lessons and Challenges

BackgroundThe COVID-19 pandemic significantly impacted the delivery of cancer screening. The resulting decrease in outpatient visits and cancellations of non-urgent procedures have negatively affected colorectal cancer (CRC) screening. We aimed to determine the effect of the pandemic on CRC screening at a safety-net hospital and a private health system based in New York City.MethodsWe identified individuals eligible for CRC screening aged 50 to 75 years presenting for outpatient care at a safety-net public hospital and private health system in April through September of 2019 and 2020. The primary outcome was the proportion of screening-eligible patients seen in primary care who underwent CRC screening.ResultsThe safety-net hospital had 516 (6.1% of screening-eligible individuals) and 269 (4.3%) screening tests completed in 2019 and 2020, respectively (p < 0.01). Fecal immunochemical tests (FIT) accounted for 69.6% of screening in 2019 and 88.1% in 2020. Colonoscopy accounted for 20.3% of screening in 2019 and 11.9% in 2020. The private health system had 39 (0.7%) and 21 (0.6%) screening tests completed in 2019 and 2020, respectively (p = 0.48). FIT accounted for 61.9% of screening in 2019 and 57.1% in 2020. Colonoscopy accounted for 38.1% of screening in 2019 and 42.9% in 2020.ConclusionAbsolute numbers of screening tests decreased for both institutions during the COVID-19 pandemic. We observed a decrease in screening uptake and increase in proportional FIT use in the safety-net hospital but no change in the private health system.

Patients who have never completed a fecal immunochemical test (FIT) may benefit from phone-based discussions about the importance of colon cancer screening before receiving the FIT in the mail. Colorectal cancer is the second-leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinxs. In 2015, only 63% of eligible adults, and 50% of Latinxs, were up to date with colorectal cancer screening recommendations. Mailed FIT outreach programs have been shown to improve colorectal cancer screening rates in community health centers, with improvements ranging from 22% – 45%. Despite the widespread use of primers and reminders for mailed FIT outreach programs, data are sparse on how these communications influence FIT completion rates. Data from our previous evaluation of mailed FIT outreach showed that adults who have never completed a FIT have a much lower FIT return rate than adults who have (17.1 vs 45.1; p &amp;lt; 0.01). As part of the Participatory Research to Advance Colon Cancer Prevention (PROMPT), which involved a partnership with a Los Angeles-based community health center that provides medical services to 300,000 patients annually (82% are Latinx), we tested whether patients who had never completed a FIT could benefit from phone-based discussions about the importance of colorectal cancer screening. Eligible patients were 50-74, due for their screening, and assigned to a wedge 1 clinic (n = 8 clinics; 6,872 patients). A total of 2,825 patients had no electronic health record evidence of having completed a prior FIT. These patients were randomized to receive the text primer (n = 1,622) or live call primer (n = 1,203). All live primer calls were delivered by bilingual health education staff trained by the research team. Patients were then mailed a FIT kit with an introductory letter and wordless instructions on completing the FIT, followed by two automated phone call reminders and live reminder calls delivered by the care team. We used logistic regression to compare the effectiveness of live call vs text message primers on FIT completion rates 3 months after the FIT mailing. Randomized patients (who had never completed the FIT) had a mean age of 58 years (SD, 6.0), 51% were female, and 80% Latinx. In the text primer arm, the overall FIT completion rate was 14.7%, and 14.6% among those who were successfully delivered the text primer. In the live call arm, the overall FIT completion rate was 18.8%, and 30.0% among those who had a discussion with health education staff. Controlling for age, preliminary analyses indicate that patients who received a live call were 1.35 times more likely to complete a FIT within 3 months of the mailing than those who received a text message primer (OR=1.35 [1.10, 1.64]). Live phone call primers, delivered before the FIT is mailed, boost screening rates among those who have never completed a FIT. Note: This abstract was not presented at the conference. Citation Format: Jamie Thompson, Denis Nyongesa, Amanda Petrik, Melissa Castillo, Gloria Coronado. Do phone-based discussions about the importance of colorectal cancer screening delivered before a fecal immunochemical test (FIT) mailing improve return rates? [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C129.

Purpose: We partnered with a local Federally Qualified Health Center (FQHC) to test implementation of evidence-based interventions (EBI) promoting Fecal Immunochemical Test (FIT) CRC screening in an environment in which colonoscopy has been the prevailing screening strategy. We report on implementation adaptations and preliminary results. Background: Sociocultural and medical concerns are barriers to colonoscopy uptake in some populations. An additional barrier to CRC screening is system level capacity for colonoscopy that results in a back log of cases and long wait times. With Covid-19, the additional backlog in overdue CRC screening has underscored the need to expand FIT testing capacity to address screening needs and to pre-empt further racial/ethnic and SES disparities in CRC outcomes. This trial tests the unique and additive value of multiple EBIs for increasing CRC screening (primarily through FIT testing, but also colonoscopy when indicated) while evaluating the success of implementing these approaches. EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and assistance from community health workers. Methods: Participants (3500), ages 45-75, were identified from a large FQHC in New Haven, CT and determined to be overdue for CRC screening. Participants were randomly assigned to one of the four arms of the study: 1) Provider reminder (overdue for CRC screening) only; 2) Provider Reminder + SDOH short message and one-size-fits all link to resources; 3) Provider Reminder + SDOH short message and offer for individualized navigation (trained navigators from local community) to address SDOH and other barriers; 4) Provider Reminder + offer to participate in a CRC educational program as phase 2 of the NCI's Screen to Save program (not an EBI). Preliminary data on uptake of CRC screening will be presented. Results: With input from stakeholders, we have: 1) lowered age eligibility from 50 to 45 to align with new guidelines; 2) expanded the target population to 2 additional satellite clinics, more than doubling the proposed study enrollment; 3) incorporated design changes in the patient reminders. The collaboration between research team and clinician stakeholders has been critical in minimizing disruptions to clinical workflow while assuring fidelity to the evidence-based interventions. Preliminary outcomes (within one month of intervention) on uptake of intervention across the 4 arms of the study, i.e., referral for CRC screening and test completion will be presented. Conclusion: The unique challenges of this urban community of primarily African American/Black, Hispanic/Latinx and/or low socioeconomic status individuals stem from the disproportionate burden of SDOH barriers. Findings will inform primary care setting implementation of EBIs to address the anticipated increase in disparities in CRC screening, exacerbated by COVID-19 changes in health care access and utilization, as well as the increased demand associated with the change in guidelines. Citation Format: Beth A. Jones, Sakinah C. Suttiratana, Sally A. DeGiovanni, Levita Y. Robinson, Michael J. Couturie, Denise Stevens, Monique K. Stefanou, Jose DeJesus, Eduardo Reyes, Jonathan Colon, Maryanne Cosgrove, Steven J. Parra. Implementing evidence-based interventions (EBI) to increase uptake of fecal immunochemical test (FIT) colorectal cancer (CRC) screening in Vulnerable Populations [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-025.

This study aimed to (1) compare colorectal cancer (CRC) screening rates among patients receiving mailed fecal immunochemical testing (FIT) versus in-clinic FIT and (2) assess the impact of various reminder interventions versus no extra reminder on mailed FIT completion. FIT is a first-line method for CRC screening. However, no research has compared screening completion in patients receiving FIT through mail (mailed FIT) versus patients receiving FIT from a provider in a clinic setting (in-clinic FIT), both of which have significantly different workflows. Furthermore, limited research has compared whether varying reminder strategies improve mailed FIT completion. This quality improvement prospective cohort study conducted at the Providence Veterans Affairs Medical Center included patients due for average-risk CRC screening. Sixteen hundred patients were mailed FIT, and if FIT was not returned within 1 month they were randomized to the following reminders: no extra reminder, personal phone call, personal voicemail, mailed postcard. Simultaneously, 1769 patients received in-clinic FIT. Three-month return and result rates were compared between mailed versus in-clinic FIT, as well as across the different mailed FIT reminder interventions. Mailed FIT return (36%) and result (34%) rates were significantly higher than in-clinic FIT return (28%) and result (24%) rates (both P<0.0001). Phone calls were the most effective mailed FIT reminder (29% return rate), significantly outperforming the no extra reminder group (21% return rate, P=0.02). Mailed FIT demonstrated higher efficacy and should be implemented in conjunction with in-clinic FIT. Phone call reminders should be incorporated into the mailed FIT workflow.

Background: Alaska Native people are committed to increasing colorectal cancer (CRC) screening to reduce the high rate of CRC in this population. We conducted a community-level cluster randomized controlled trial (RCT) to evaluate the impact of multi-target stool DNA test introduction (mt-sDNA; Cologuard® Exact Sciences, Madison WI) on CRC screening in southwest Alaska Native communities using a mt-sDNA pre-processing lab in Anchorage, Alaska. Methods: A total of 32 rural/remote Alaska Native communities were evenly randomized to either high intensity patient navigation or medium intensity mailed health education compared to 14 communities receiving standard of care (screening recommendations at health care visits). The intervention was conducted from April 2021-February 2023. Outcome measures included CRC screening completion within 12 months and method used (mt-sDNA vs colonoscopy). Results: A total of 2032 Alaska Native participants (mean [SD] age, 56 [8.4] years; 817 women [40%]) were enrolled: 587 participants randomized to usual care, 696 participants randomized to the mailed education arm, and 749 participants randomized to the patient navigation arm. The mt-sDNA test was significantly preferred over colonoscopy by both mailed education participants (68%) and patient navigation participants (71%) (p&amp;lt;0.01). Mt-sDNA was somewhat more preferred by older participants ages 65-75 (79%) vs younger participants ages 45-54 (64%). Both men (71%) and women (68%) significantly preferred mt-sDNA compared with colonoscopy (p&amp;lt;0.01). Overall, 38% of those in the patient navigation intervention completed screening compared with 33% in the mailed education intervention and 10% in the usual care arm. No significant differences were observed in mt-sDNA completion between the patient navigation arm (154 participants [40%]) and the mailed education arm (100 participants [36%]) (p= 0.34). Colonoscopy completion (not including follow-up colonoscopies after abnormal stool tests) was higher in both the patient navigation arm (112 participants [44%]) and the mailed education arm (87 participants [43%]) compared with usual care (38 participants [14%]). Over 61% of kits sent to participants were completed and returned, however, 38% of the kits were not able to be processed, primarily because of mail transit time exceeding the manufacturer’s collection-to-processing limitation of 72 hrs. Conclusions: In this RCT among Alaska Native peoples who were not up to date with CRC screening recommendations, both a mailed education intervention and a patient navigator facilitated intervention were effective at increasing CRC screening compared with usual care. Participants overwhelmingly preferred mt-sDNA for screening but limitations in getting samples to the lab in time for analysis meant that about one-third of mt-sDNA samples were unable to be processed. These findings show that screening outreach and mt-sDNA use can substantially increase CRC screening, but shipping and weather issues remain to be addressed for expanding use of mt-sDNA in rural/remote Alaskan communities. Citation Format: Diana Redwood, Christie Flanagan, Lauren Jeffries, Peter Holck, Danika Bailie, Christine Desnoyers, Joseph Klejka, Lila Rutten, John Kisiel. Increase in colorectal cancer screening among rural and remote Alaska Native peoples using the multi-target stool DNA: A randomized controlled trial [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr A148.

PURPOSE: Partnering with the largest Federally Qualified Health Center (FQHC) in New Haven, CT, the goal is to implement and test 4 evidence-based interventions (EBI) to increase CRC screening, while evaluating real-world implementation. Here, we report on the six-month (approximate) follow up of a cohort of 3,127 patients overdue for CRC screening who received 1 or more EBIs in October 2021. BACKGROUND: Sociocultural and medical concerns are barriers to colonoscopy uptake contributing to disparities in CRC screening. An additional barrier is system level capacity. COVID-19 associated delays exacerbated the existing backlog of individuals overdue for CRC screening, underscoring the need to expand Fecal Immunochemical Testing (FIT) capacity. This was particularly evident in the safety-net primary care setting that serves lower socio-economic status individuals living in urban New Haven, CT. METHODS: We are testing the unique and additive value of multiple evidence-based interventions (EBIs) for increasing CRC screening. The EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and providing assistance from community health workers (CHW). We randomized 3,127 patients overdue for CRC screening to one of 4 arms of the study. All individuals received a reminder from their providers that they were due/overdue for CRC screening with instructions to contact the FQHC. Arm 2 also included information on SDOH barriers, Arm 3 included this same information with offer of navigation from CHW/navigator; and Arm 4 included the offer of CHW educational video and support if needed. Six-month (approximate) outcomes include: 1) Engagement with FQHC resulting in ordered test; 2) completed test. Results by intervention will be assessed at 12 months. RESULTS: Of the 3,127 randomized patients, ages 50-75, 77% were Hispanic (33%) or Black (44%). At 6+ months, a preliminary look at EMR data show that a minimum of 1,275 (40.8%) patients “engaged” with providers resulting in an ordered FIT Kit (n= 1174) or COMPLETED screening colonoscopy that was not associated with a positive FIT result (n = 102). 217 (18.5%) individuals completed the FIT testing with 13 requiring confirmatory colonoscopy (31% completed at this time). Thus, a minimum of 319 (10%) of 3,127 individuals in the cohort completed CRC screening at approximately 6 months post intervention. DISCUSSION: Despite investments in community engagement, stakeholder input, and FIT kit capacity building, the pandemic presented unforeseen challenges. Flexibility and steadfast commitment from FQHC providers and staff were critical to successful implementation during multiple waves of COVID-19, resulting in CRC screening ordered for 41% of cohort within 6 months of intervention. SUMMARY: At 6 months follow up of 3,127 individual who were overdue for CRC screening, one or more of 4 EBIs, in addition to system level efforts to address CRC screening, resulted CRC screening tests ordered for 41% of cohort with at least 10% completed screening. Citation Format: Beth A. Jones, Sakinah C. Suttiratana, Sarah A. DeGiovanni, Steven J. Parra, Levita Robinson, Michael Couturie, Louie Mar Gangcuangco, Denise Stevens. Partnering with primary care to implement evidence based interventions (EBI) to address overdue colorectal cancer (CRC) screening in Connecticut (CT) [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A104.

This study assessed the referral and completion rates of colorectal cancer screening with fecal immunochemical test (FIT) in a primary care medical home serving an underserved population. The Good Samaritan Clinic (Clinic) provides medical care to over 600 uninsured clients annually and is staffed by volunteer health care providers (Providers). All clients have an income at or below 200 % of the Federal Poverty Line; 63.8 % are Latino or Hispanic, 22.3 % are non-Hispanic Caucasians, and 10.1 % are African American. Acute client care for co-morbidities such as hypertension and uncontrolled diabetes is often the focus of clinical visits, thus limiting health promotion referrals, including routine cancer screenings. To promote evidence-based recommended cancer screenings the Clinic and the Lewis Cancer &amp; Research Pavilion utilized guidelines from the American Cancer Society, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network to create a Cancer Assessment Tool (CAT) with age and sex appropriate screenings for breast, cervical, prostate, colorectal, and head and neck cancers. This cancer screening intervention was implemented in March 2013. During clinic visits, Providers used the CAT to review age and sex recommended cancer screenings and then, based on the CAT, referred clients as indicated. For example, if colorectal cancer screening was indicated based on age or family history, the CAT prompted the Provider to give the client a FIT to take home and to also counsel the client on how to collect the sample and return the test. No other interventions to promote FIT referral, FIT completion, or other colorectal screening methods were implemented during this time. To evaluate Provider FIT referrals and client FIT return compliance, data on CAT implementation was collected from March 28 – July 31, 2013. Measurements collected included the number of clients eligible for age-appropriate colorectal cancer screening; the number of clients with whom the CAT was completed; the number of clients given FIT; the number of FIT returned; and the number of positive FIT. Providers utilized the CAT to consider screening for colorectal cancer based on age and family history with 25.5 % (110) of the 431 total clients seen at the Clinic during this time period. Review of medical records indicate that 34.8 % (150) of total clients met age only criteria (over age 50) for colorectal cancer screening. Of the 150 total age-eligible clients (not considering additional clients with family history), 44.7 % (67) were referred for colorectal screening and were given a take-home FIT. Of the 67 clients given a FIT, 53.7 % (36) returned the results, resulting in a FIT completion rate of 24 % of all 150 age-eligible clients. 100 % (36) of FIT exams returned were negative. FIT drop-off occurred at both the provider referral level (55.3 % non-referral rate) and the client completion level (46.3 % non-completion rate). Based on these drop-off points several provider and client-based interventions recommended by the Guide to Community Preventive Services (Community Guide) may support improved colorectal cancer screening completion. First, strengthening provider-based interventions such as provider feedback and reminder systems so that the CAT is utilized for all client visits may support increased referral for FIT screening. Second, client-based interventions such as one-on-one education, client reminders such as follow-up phone calls, and reducing structural barriers such as putting postage stamps on the FIT may support client compliance to complete and return the FIT. Potential exists to conduct similar analysis of the CAT with breast, cervical, prostate, and head and neck cancers. Citation Format: Sarah Dobra, Krista Aliffi, Sandra Bond. Referral and completion rates for colorectal cancer screening with fecal immunochemical test (FIT) in a medical home for underserved populations. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr B75. doi:10.1158/1538-7755.DISP13-B75

Background: In Romania, colorectal cancer does not benefit yet from a national screening program. In order to decrease the harm and burden of colorectal cancer (CRC), opportunistic programs relying on endoscopy has been adopted by each centre according to its capacity. A colorectal cancer (CRC) screening programme based on faecal immunochemical test (FIT) was launched at Ponderas Academic Hospital (PAH) in 2019. Aim: The present study analyses the outcomes after the first 1500 tests in the PAH-FIT-CRC Screening Program. We have also aimed to compare the efficiency of the FIT testing program with the screening colonoscopies performed in our Center, withing the same time interval (2019). Methods: The test was recommended in asymptomatic patients over 45 years, and it was followed by a colonoscopy when the test results were positive. Furthermore, we performed a retrospective observational study gathering data from all the consecutive patients prospectively included in the respective databases of our hospital, comparing the efficacy of the two colorectal cancer screening methods (FIT versus colonoscopy). Results: Between 01.01.2019 and 01.01.2020, 1524 screening colonoscopies were performed, and the resulting data were compared with those obtained in the FIT group (1500 FIT tests freely distributed). In the screening colonoscopy group, the polyp detection rate was 38.98% and 22 (1.44%) adenocarcinomas were identified. In the FIT group, the FIT uptake rate was 71% with a positivity rate of 21.7%. The colonoscopy compliance rate for positive FIT patients was 29.4%, with only 2 adenocarcinomas detected. Conclusions: Following data analysis, the need for improvement of uptake rate and colonoscopy compliance rate was suggested, due to the lower acceptance of FIT tests and colonoscopies, especially among men. Moreover, special efforts should be made in order to improve quality indicators for screening colonoscopies (especially adenoma detection rate) with the purpose of decreasing interval CRC.

Population health interventions to improve colorectal cancer screening by fecal immunochemical tests: A systematic review

The rates of colorectal cancer (CRC) screening in the U.S. remain below national targets, so many people at risk are not being screened. The objective of this qualitative research project was to assess patient and provider knowledge and preferences about CRC screening modalities and specifically the use of the fecal immunochemical test (FIT) as a first line screening choice. Nine focus groups were conducted with a medically underserved patient population and qualitative interviews were administered to their medical providers. Thematic analysis was used to synthesize key findings. Both providers and patients thought that the FIT would be a good option for CRC screening both as an individual choice and for an overall program approach. The test is less expensive and therefore more readily available for patients compared to colonoscopy. Overall, there was consensus that the FIT offers a reasonably priced, simple approach to CRC screening which has broad appeal to both providers and patients. Concerns identified by patients and providers included the possibility of false positives with the FIT which could be caused by test contamination or failing to perform the test properly. Patients also described feelings of disgust toward performing the FIT and difficulties in following the instructions. Study findings indicate provider and patient support for using the FIT for CRC screening at both the individual and system-wide levels of implementation. While barriers to the use of the FIT were listed, benefits of using the FIT were perceived as positive motivators to engage previously unscreened and uninsured or under-insured individuals in CRC screening.

Marked health disparities exist in colorectal cancer (CRC) screening, incidence, and mortality among medically-underserved communities. Literature suggests certain health beliefs (e.g., perceived risk) may be related to screening behavior. This study examined changes in CRC health beliefs following receipt of one of two educational interventions aimed at promoting CRC screening uptake among a medically-underserved population. We compared changes in CRC health beliefs at baseline and 12 months later both within and between the two intervention groups. Enrolled participants were aged 50-75, at average CRC risk, not up-to-date with CRC screening guidelines, enrolled in a randomized controlled trial to increase CRC screening that was conducted at community clinics in the Tampa Bay area, and completed both the baseline and 12 month follow-up assessments. Participants were randomized to receive either a culturally-targeted photonovella and DVD plus fecal immunochemical test (FIT) intervention (titled Colorectal Cancer Awareness, Research, Education and Screening, or CARES, intervention group condition) or a Centers for Disease Control and Prevention (CDC) standard educational brochure plus FIT intervention (comparison group condition). At both time points, participants completed a questionnaire that included multiple health-related beliefs including Preventive Health Model (PHM) constructs (i.e., perceived susceptibility, perceived salience, self-efficacy, response efficacy, cancer worry, social influence, and religious beliefs), CRC awareness, decisional conflict regarding CRC screening, cancer fatalism, trust in the healthcare system, and perceived discrimination. Changes in health belief scores and group differences in change were examined using Student's t-tests. The majority of participants (n=270) were: female (58%); white (67%) or black (26%); insured (59%) including county health insurance; had a household income &amp;lt;$10,000 (65%); and had a high school education (35%) or more than high school education (41%). In both intervention conditions, there was an increase in CRC awareness, PHM social influence, and trust in the healthcare system (all p's&amp;lt;.0001). In the CARES intervention group, there also was an increase in PHM salience (p&amp;lt;.05). Among individuals in the comparison group, there was an increase in PHM response efficacy (p&amp;lt;.01) and PHM self-efficacy (p&amp;lt;.0001). There were no significant between-group differences on any of the health belief change scores. Both CRC screening interventions promoted positive changes in multiple health beliefs from baseline to 12 months which suggests clear benefits of educational interventions. The interventions had common positive effects (i.e., CRC awareness, PHM social influence, and trust in the healthcare system), but also unique effects on PHM salience (CARES condition) and PHM self-efficacy and PHM response efficacy (comparison condition). However, between-group intervention comparisons were not significant suggesting that both educational interventions are beneficial. Given that individuals in both intervention groups were provided with access to CRC screening via FIT kit, future analyses will examine whether changes in health beliefs were associated with higher CRC screening uptake. Citation Format: Shannon M. Christy, Steven K. Sutton, Enmanuel Chavarria, Stacy N. Davis, Rania Abdulla, Gwendolyn P. Quinn, Susan T. Vadaparampil, Chitra Ravindra, Ida Schultz, Richard Roetzheim, David Shibata, Cathy D. Meade, Clement K. Gwede. Changes in health beliefs among medically-underserved patients enrolled in a community-based randomized controlled trial to promote colorectal cancer screening. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A63.