Fecal Immunochemical Test Kit Research Articles

Association of circulating nucleosomes levels with FIT performance for advanced adenomas in a symptomatic population.

170 Background: The effectiveness of screening using either fecal immunochemical testing (FIT) or colonoscopy in reducing colorectal cancer (CRC) mortality has been demonstrated in previous studies. Nevertheless, the single test sensitivity of FIT for relevant precursor lesions, especially high-risk neoplasms like invasive cancer or advanced adenomas (AA), is a concern. Improving the sensitivity for high-risk neoplasm is critical to improving the effectiveness of screening in reducing CRC incidence and mortality. Dysregulation of histone post-translational modifications (PTMs) has been linked with several cancers including CRC. We investigated the clinical performance of circulating nucleosome levels containing specific histone PTMs in blood, in combination with FIT from symptomatic subjects referred to colonoscopy to evaluate their discriminant power towards CRC and AA. Methods: 10mls whole blood was obtained prior to colonoscopy from 476 patients referred to colonoscopy in National Taiwan University Hospital for surveillance or secondary to bowel symptoms. Patients were classified into 5 groups based on their colonoscopy reports: (i) patient with CRC (n = 67), (ii) patients with AA (n = 60, including 22 with AA≥2cm); (iii) patients with non-AA (n = 123); (iv) patients with non-neoplastic polyps (n = 29); (vi) healthy controls with no endoscopic lesion (n = 197). Plasma samples were analyzed for nucleosome levels using 7 different quantitative immunoassays (Nu.Q assays; Belgian Volition SRL, Belgium) targeting H3.1-nucleosomes or different histone modifications (H3K27Me3-, H3K36Me3-, H3K9Me3-, H3K14Ac-, H3K27Ac- or H3R8Cit-nucleosomes). All study subjects were asked to collect a stool sample at home within 48-hours before the colonoscopy. The fecal samples were assayed with the OC-SENSOR FIT kit (Eiken Chemical Co., Ltd., Tokyo, Japan) for all subjects. Results: At a cut-off of 20µg/g feces, the FIT test showed a sensitivity of 83.5% at 82.1% specificity for CRC +AA vs. Controls. All the CRC patients were detected but 35% of AA were missed, and 7 of which were high-risk adenomas (AA≥2cm). A combination of 2 Nu.Q biomarkers: H3K36Me3 and H3K9Me3 with FIT in a decision tree model showed an improved sensitivity of 98.4% allowing the detection of all CRC patients and 97% of the patients with AA including all high-risk adenomas. The 2 missed AA were one AA below 1cm and one between 1 and 2cm. Unnecessary colonoscopies could be reduced by 28.9% of the control and 20.7% of the non-neoplastic polyps subgroups as both are found negative with this panel of assays. Conclusions: At present, all the symptomatic patients are sent to colonoscopy in clinical practice. Our results indicate that H3K36Me3- and H3K9Me3-nucleosome levels, in combination with FIT in a decision tree model, could detect all CRC patients and all high-risk adenomas and help reduce unnecessary colonoscopies.

Circulating nucleosomes for detection of colorectal cancer and high-risk advanced adenomas.

169 Background: Detection and treatment of early colorectal cancer (CRC) or advanced adenomas (AA) is the key for superior outcomes and fecal immunochemical testing (FIT)-based screening has proven effective in reducing CRC death and the risk of advanced-stage CRC but the discrepancy in the effectiveness was observed between proximal and distal cancers. On the other hand, false-positive results of FIT with 60 % of negative colonoscopy is another concern, considering the burden to the screening participants and the healthcare providers. A blood-based test as an alternative or supplement to FIT has the potential to concurrently enhance the detection of high-risk neoplasms and identify individuals at risk who should then be referred to colonoscopy. We investigated the levels of circulating free nucleosomes containing different epigenetic modifications in patients referred for colonoscopy. Methods: 10mls whole blood was obtained from 520 asymptomatic patients prior to colonoscopy at National Taiwan University Hospital. Patients were classified into 5 groups based on their colonoscopy reports: (i) patient with CRC (n = 33), (ii) patients with AA (n = 123, including 18 with AA > 2cm); (iii) patients with non-AA (n = 168); (iv) patients with non-neoplastic polyps (n = 30); (vi) healthy controls with no endoscopic lesion (n = 166). Plasma samples were analyzed for nucleosome levels using 7 different quantitative immunoassays (Nu.Q assays; Belgian Volition SRL, Belgium) targeting H3.1-nucleosomes or different histone modifications (H3K27Me3-, H3K36Me3-, H3K9Me3-, H3K14Ac-, H3K27Ac- or H3R8Cit-nucleosomes). All study subjects were asked to collect a stool sample at home within 48-hours before the colonoscopy. The fecal samples were assayed with the Eiken OC-SENSOR FIT kit (Eiken Chemical Co., Ltd., Tokyo, Japan) for all study subjects. Results: At a cut-off of 20µg/g feces, the FIT test showed a sensitivity of 92,9% at 17.5% specificity for CRC +AA vs. Controls. All the CRC patients and 83.3% of the high-risk AA (> 2cm) patients were FIT positive. A combination of 2 Nu.Q biomarkers: H3K27Me3 and H3R8Cit with FIT in a logistic regression model showed improved sensitivity of 95% at 20.6% specificity allowing the detection of all CRC patients and 94.3% of AA patients including all the high-risk adenomas. The FIT test detected 46 out of 55 proximal adenomas whereas the combined model could detect 50 proximal adenomas including 3 proximal AA > 2cm not being detected by FIT (p < 0.05). The same combination would reduce unnecessary colonoscopies by 21.8% of the control and 23.3% of the non-neoplastic polyps subgroups compared to 17.5% and 6.7%, respectively with the FIT test alone. Conclusions: Our results indicate that H3K27Me3 and H3R8Cit-nucleosome levels in combination with FIT could improve the detection of proximal high-risk AA and could also provide a non-invasive method to reduce unnecessary colonoscopy.

Faecal immunochemical test for suspected colorectal cancer symptoms: patient survey of usability and acceptability.

BackgroundRecent evidence suggests that the faecal immunochemical test (FIT) can rule out colorectal cancer (CRC) in symptomatic patients. To date, there is no research on usability and perception of FIT for these patients.AimTo measure variation in attitudes and perception of FIT in patients with suspected CRC symptoms.Design & settingA cross-sectional survey of a subset of participants of the NICE FIT study.MethodA questionnaire was co-developed with patients covering four themes on a Likert scale: FIT feasibility, faecal aversion, patient knowledge, and future intentions. Questionnaire and FIT kits were sent to patients with suspected CRC symptoms participating in the NICE FIT study. Logistic regression explored differences in patients’ test perception by ethnic group, language, age, location, deprivation, FIT use, and previous experience.ResultsA total of 1151 questionnaires were analysed; 90.2% (95% confidence interval [CI] = 88.3% to 91.8%) of patients found faecal collection straightforward, 76.3% (95% CI = 73.7% to 78.6%) disagreed FIT was unhygienic, and 78.1% (95% CI = 75.6% to 80.4%) preferred FIT to colonoscopy. Preference for FIT over colonoscopy was weaker in patients aged 40–64 years than those >65 years (odds ratio [OR] 0.60; 95% CI = 0.43 to 0.84). Intention to use FIT again was stronger in patients who successfully used FIT than those unsuccessful (OR 11.08; 95% CI = 2.74 to 44.75), and white compared with non-white patients assessed (OR 3.20; 95% CI = 1.32 to 7.75).ConclusionWhile most patients found FIT practical and hygienic, perception differences were found. Strategies to engage patients with more negative FIT perception should underpin symptomatic FIT pathways.

S250 Increasing Fecal Immunochemical Test Return Rates by Patient Reminders: A Quality Improvement Study

Introduction: The incidence of colorectal cancer (CRC) in the United States is increasing, and it remains the second leading cause of cancer death in the United States for men and women combined. The American Cancer Society now recommends that adults aged 45 years and older with an average risk of CRC undergo regular screening with either a high sensitivity stool-based test or structural (visual) examination, depending on patient preference and test availability. The primary objective of this quality improvement project was to determine if reminder methods, such as telephone or letter reminders, increased the return rate of fecal immunochemical tests (FIT) for colorectal cancer screening. Methods: At public outreach events and daily clinics in the West Texas Panhandle area, participants in the GET FIT program were provided with FIT kits after completing the education on colorectal cancer. Participants who fit the inclusion criteria and had received a FIT kit from the program were included. They were instructed on how to perform the test and mail it back. Participants that did not return the completed kits within two weeks were reminded either by 1) through a reminder letter or 2) by telephone every 2 weeks (+/- 3 days) for 60 days or 5 attempts to contact. We de-identified and analyzed the FIT kit return data from June-November 2019 before instituting these reminder methods. We then calculated the change in return rates from December 2019 to February 2020. Our goal was to increase the FIT return rates by 25% over the baseline return rate. Results: The pre-intervention return rate of kits for June-November 2019 was 67.58%, and the postintervention return rate for December 2019-February 2020 was 81.87%. This rate was equal to an approximately 21% increase in return rates. The average return rate of FIT kits overall was 72.34%. The average rate of returned new patient kits was 69%, and the average % of new patient return kits was 68.51%. We also noticed a significant increase in return of FIT tests after a community cancer screening in October 2019. Conclusion: Fecal immunohistochemical test (FIT) remains one of the primary options for colorectal cancer screening. Due to its lower cost and noninvasiveness, FIT was offered to patients at average risk.We did achieve a significant increase in return rates, although we did not meet our target goal for this project. Our project was limited to studying 3 months post-intervention due to the COVID pandemic and barrier in returning tests. (Table Presented).

S307 The FIT Initiative: A VA Quality Improvement Initiative to Improve Colorectal Cancer Screening

Introduction: The fecal immunochemical test (FIT) is a validated test for colorectal cancer screening for average risk individuals over the age of 45 as per the latest guidelines from the United States Preventative Task Force1. Using antibody-hemoglobin complexes, the test identifies human hemoglobin in a stool sample with a sensitivity of 74% and specificity of 94%1,2. A positive FIT test requires a follow-up colonoscopy for the detection and removal of pre-cancerous lesions. During the fiscal year (FY) 2020, 62% of returned FIT kits at the Veterans Administration Hospital were sent back incorrectly. This inefficiency led to increased cost/wasted product, delay in cancer detection, and dissatisfaction for patients and providers alike. Furthermore, the COVID-19 pandemic urged social distancing measures, which increase FIT kit usage since in-person colonoscopies were deferred. Methods: The ambulatory quality improvement project sought out root causes for the incorrectly returned FITs and proposed PDSA cycles based on a series of approved action plans. The multidepartment team composed of individuals from lab, nursing, administrative staff, and primary care came together virtually and discovered 6 major root causes. The 80/20 rule was applied to our pareto chart of root concerns and a frequency vs risk chart was made to highlight our major problems. Our assessment showed that lack of written collection date was the biggest issue and thus a PICK chart was assembled to prioritize our future solutions. Our multi-pronged PDSA (Plan, Do, Study, Act) cycle attempted to set up redundant patient reminders, centralize the FIT dispersal process and make the patient-FIT interface more user-friendly. All our PDSA solutions were implemented over the course of 4 months. Results: Preliminary data has shown that the average percentage of incorrectly returned FITs due to lack of written collection date has decreased by 38.56% as of May 2021. Conclusion: As with any quality improvement process, an overhaul in process can bring up new issues. Due to frequent assessments through this project, we were able to troubleshoot a number of human factor engineering issues that arose between staff and FIT kits. Our aim is to continue these efforts throughout FY 2021 and attempt to improve our FIT screening capability at the VA.

Health plan-based mailed fecal testing for colorectal cancer screening among dual-eligible Medicaid/Medicare enrollees: Outcomes of 2 program models.

Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.

Case Study of a Comprehensive Team-Based Approach to Increase Colorectal Cancer Screening.

IntroductionColorectal cancer is the second leading cause of cancer deaths among men and women in West Virginia. In addition, 51% of all colorectal cancers diagnosed in West Virginia from 2012 to 2016 were detected at either regional (31%) or distant (20%) stages indicating a need for improved early detection.MethodsWest Virginia University Cheat Lake Physicians participated in the West Virginia Program to Increase Colorectal Cancer Screening, a program of Cancer Prevention and Control at the WVU Cancer Institute. As a result, Cheat Lake Physicians assembled a team of health care professionals to implement evidence-based interventions and system changes including provider assessment and feedback, patient reminders, accurate data capture, and tracking of CRC screening tests.ResultsThese efforts resulted in a 15.8% increase in colorectal cancer screening rates within one year of implementation. Additionally, the clinic achieved a 66% return rate for Fecal Immunochemical Test kits, an inexpensive, stool-based colorectal cancer screening test.ImplicationsThe utilization of a team-based approach to patient care yields positive results that can be carried over to other cancer and disease prevention efforts in primary care clinics.

Abstract 2543: Venue-based recruitment to increase colorectal screening rates using fecal immunochemical test in Essex County, New Jersey

Abstract Background: Overall, Essex County, New Jersey's age-adjusted prevalence for completion of colorectal cancer screening is 71.5%; however, Black and Latinx residents have a lower colorectal cancer screening rate of 65%. To increase urban residents' colorectal screening rates, we used venue-based recruitment to educate the community about fecal immunochemical testing. Methods: Education about fecal immunochemical testing was implemented at community-based events following a colorectal cancer education session. These sessions were carried out in English, Spanish, and Portuguese. Eligibility criteria included the following: (1) between the ages of 45-85 and (2) not current with U.S. Preventive Services Task Force recommended colorectal cancer screening. Eligible participants who agreed to participate were provided a fecal immunochemical testing kit and instructed to complete these kits to be returned within two weeks. Patient navigators followed up with study participants to explore barriers to completion and facilitate the fecal immunochemical testing kit's timely return. Results: Approximately 132 participants received the fecal immunochemical testing kit, and 55% were returned. On average, participants who received the fecal immunochemical testing kit were at least 60 years of age, 11% were men, 71% indicated no primary care provider, 72% reported no health insurance, and 81% reported no prior colorectal cancer screening. Of the 55% of the fecal immunochemical testing kit that was returned, 9 (12%) were positive for occult blood, and two diagnostic colonoscopies were completed. Participants noted several barriers to completing and returning the fecal immunochemical testing kit. They noted the following barriers: misplaced or loss of fecal immunochemical testing kit, limited time, and perceived comfortability of handling a stool sample. Discussion: Targeting study participants at community-based events may increase access to colorectal screening for underserved populations. Barriers to colorectal cancer screening could be mitigated by co-locating colorectal cancer screening education in the community. Citation Format: Luis Alzate-Duque, Pamela Valera, Vivian Cueto, Ashna Shome, Ana Natale-Pereira. Venue-based recruitment to increase colorectal screening rates using fecal immunochemical test in Essex County, New Jersey [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2543.

Healthcare provider cultural competency and receptivity to colorectal cancer screening among African Americans

ABSTRACT African Americans suffer disproportionately from colorectal cancer (CRC), due in part to disparities in CRC screening. Better understanding culturally relevant psychosocial factors that impact CRC screening is therefore critical. This study examined how African Americans’ perceived cultural competency of their physician is associated with receptivity to take-home stool-based CRC screening. CRC screening deficient African Americans (N = 457) completed a patient-focused measure of perceived cultural competency and watched a brief video about CRC risks, prevention, and screening. Receptivity to stool-based CRC screening was measured using Theory of Planned Behavior (TPB) constructs . Participants were also given an opportunity to receive a no-cost at-home Fecal Immunochemical Test (FIT) kit, and we measured acceptance of this offer as a behavioral outcome (yes-no). Results showed that perceived cultural competency was associated with higher receptive attitudes, more favorable norms, greater perceived behavioral control towards stool-based screening, and also greater intentions to engage in FIT Kit screening (p < 0.001). We also found significant indirect effects of perceived cultural competency on FIT kit uptake through intention-mediated pathways. This study provides crucial evidence that participants’ perceived cultural competency may play an important role in preventive health behavior among racial minorities, including CRC screening uptake among African Americans.

Colorectal cancer in patients with single versus double positive faecal immunochemical test results: A retrospective cohort study from a public tertiary hospital.

BackgroundScreening for colorectal cancer (CRC) using the faecal immunochemical test (FIT) is widely advocated. Few studies have compared the rate of detecting colonoscopic pathologies in single compared to double FIT-positive follow-up colonoscopy-compliant individuals in a two-sample national FIT screening program.ObjectiveTo compare CRC incidence in double FIT-positive versus single FIT-positive individuals using a retrospective cohort of patients from a tertiary hospital in Singapore.DesignRetrospective cohort study.SettingData was extracted from one public tertiary hospital in Singapore.Participants1,422 FIT-positive individuals from the national FIT screening program who were referred to the hospital from 1st January 2017 to 31st March 2020 for follow-up consultation and diagnostic colonoscopy.MeasurementsThe exposure of interest was a positive result on both FIT kits. The main outcome was a follow-up diagnostic colonoscopy finding of CRC. The secondary outcome was a diagnostic colonoscopy finding of a colorectal polyp.ResultsIncidence density of CRC was 1.15 and 13.10 per 100,000 person-months, in the single and double FIT-positive group, respectively. This resulted in an incidence rate ratio of 11.40 (95% CI = 4.34, 35.09). Colorectal polyp detection was significantly higher (p < 0.01) in the double (103 of 173 participants; 59.5%) compared to the single (279 of 671 participants; 41.6%) FIT-positive group.LimitationsThe key limitation of this study was the relatively small cohort derived from a single tertiary hospital, as this had the effect of limiting the number of incident cases, resulting in comparatively imprecise CIs.ConclusionsDouble FIT-positive individuals are significantly more likely to have a colonoscopy finding of incident CRC or premalignant polyp than single FIT-positive individuals. Clinicians and policymakers should consider updating their CRC screening protocols accordingly.

Impact of changing from a guaiac faecal occult blood test to a faecal immunochemical test in a national screening programme: Results from a pilot study within the national bowel cancer screening programme in England.

Testing for occult blood in faeces is widely used in bowel cancer screening around the world. In many programmes, the faecal immunochemical test (FIT) is replacing the traditional guiaic faecal occult blood test (gFOBT). There have been a number of reports on the clinical impact of making this change; yet, no-one has considered the pre-analytical and analytical impact of moving from a gFOBT to a FIT bowel cancer screening programme. We interrogated data obtained in a FIT pilot carried out in England in 2014 to assess the timeliness of specimen collection device return time and analysis for gFOBT and FIT, the impact of time to analysis on faecal haemoglobin (f-Hb) concentration, and any differences observed between analyses carried out at two different testing laboratories. FIT kits were returned on average 5.6 days sooner than gFOBT. The time to analysis for FIT leads to an overall rise in f-Hb concentration within the manufacturer's stated 14-day stability period. Both these factors are important considerations for laboratories when considering setting up a bowel cancer screening programme, especially if transitioning from gFOBT to FIT. Our data also support previous evidence of males having a higher f-Hb than females and demonstrate that after adjusting for sex, age and screening hub, neither index of multiple deprivation nor screening episode significantly affected f-Hb.

Effects of culturally targeted message framing on colorectal cancer screening among African Americans.

This study examined how standard and culturally targeted versions of gain and loss-framed messaging affect African Americans' colorectal cancer (CRC) screening receptivity and behavior, as well as their anticipation of experiencing racism in undertaking CRC screening. Screening-deficient African Americans (N = 457) viewed an informational video about CRC risks, prevention, and screening and were randomized to receive a gain or loss-framed message about screening. Half of participants viewed an additional culturally targeted message about overcoming racial disparities in CRC by obtaining screening. Using the Theory of Planned Behavior, we measured general receptivity to CRC screening. We also measured arousal of anticipatory racism in response to messaging. Finally, we offered participants a no-cost fecal immunochemical testing kit (FIT Kit) and measured uptake and use. Message framing interacted with culturally targeted messaging to affect CRC screening receptivity and behavior. Participants were no more receptive to CRC screening when standard loss-framing was used, but were more favorable if loss-framing was culturally targeted. Targeted loss-framing also reduced anticipatory racism, which partially mediated effects on screening receptivity. Finally, although participants least often accepted a FIT Kit with standard loss-framing, effects of messaging on FIT Kit uptake and use were not significant. This study adds to growing recognition of important cultural nuance in effective use of message framing. Current finding also suggest that targeted and framed messaging could synergistically impact the extent to which African Americans engage in CRC screening, although specific impacts on FIT Kit screening are less certain. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Adaptation of the Flu-FIT Program for Patient-Aligned Care Teams: A Quality Improvement Project.

The Flu-FIT program aims to increase colorectal cancer screening rates by offering a home fecal immunochemical test (FIT) at the time of annual influenza immunization. This program was piloted at a VA campus in New Jersey during the 2018-2019 influenza season, with a 9% increase in colorectal cancer screening rates. In the 2019-2020 season, the program was implemented in 6 primary care teams; 6 additional teams maintaining standard of care served as a comparison group. A total of 816 patients aged 50 to 75 years were eligible for participation; 509 patients were available for analysis, 242 in the Flu-FIT group and 267 in the comparison group. The Flu-FIT group patients were 2.4 times more likely to accept FIT kits (95% confidence interval: 1.6-3.6, P = .001). The colorectal cancer screening rates increased 77.0% to 81.9% in the Flu-FIT group and 77.0% to 79.8% in the comparison group (P > .05).

Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial

Routine screening reduces colorectal cancer mortality, but screening rates fall below national targets and are particularly low in underserved populations. To compare the effectiveness of a single text message outreach to serial text messaging and mailed fecal home test kits on colorectal cancer screening rates. A two-armed randomized clinical trial. An urban community health center in Philadelphia. Adults aged 50-74 who were due for colorectal cancer screening had at least one visit to the practice in the previously year, and had a cell phone number recorded. Participants were randomized (1:1 ratio). Individuals in the control arm were sent a simple text message reminder as per usual practice. Those in the intervention arm were sent a pre-alert text message offering the options to opt-out of receiving a mailed fecal immunochemical test (FIT) kit, followed by up to three behaviorally informed text message reminders. The primary outcome was participation in colorectal cancer screening at 12 weeks. The secondary outcome was the FIT kit return rate at 12 weeks. Four hundred forty participants were included. The mean age was 57.4 years (SD ± 6.1). 63.4% were women, 87.7% were Black, 19.1% were uninsured, and 49.6% were Medicaid beneficiaries. At 12 weeks, there was an absolute 17.3 percentage point increase in colorectal cancer screening in the intervention arm (19.6%), compared to the control arm (2.3%, p < 0.001). There was an absolute 17.7 percentage point increase in FIT kit return in the intervention arm (19.1%) compared to the control arm (1.4%, p < 0.001). Serial text messaging with opt-out mailed FIT kit outreach can substantially improve colorectal cancer screening rates in an underserved population. clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT03479645 ).

Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol.

BackgroundShort message service (SMS) based interventions are widely used in healthcare and have shown promising results to improve cancer screening programs. However, more research is still needed to implement SMS in the screening process. We present a study protocol to assess the impact on health and economics of three targeted SMS-based interventions in population-based cancer screening programs.Methods/DesignThe M-TICs study is a randomized controlled trial with a formal process evaluation. Participants aged 50–69 years identified as eligible from the colorectal cancer (CRC) and breast cancer (BC) screening program of the Catalan Institute of Oncology (Catalonia, Spain) will be randomly assigned to receive standard invitation procedure (control group) or SMS-based intervention to promote participation. Two interventions will be conducted in the CRC screening program: 1) Screening invitation reminder: Those who do not participate in the CRC screening within 6 weeks of invite will receive a reminder (SMS or letter); 2) Reminder to complete and return fecal immunochemical test (FIT) kit: SMS reminder versus no intervention to individuals who have picked up a FIT kit at the pharmacy and they have not returned it after 14 days. The third intervention will be performed in the BC screening program. Women who had been screened previously will receive an SMS invitation or a letter invitation to participate in the screening.As a primary objective we will assess the impact on participation for each intervention. The secondary objectives will be to analyze the cost-effectiveness of the interventions and to assess participants’ perceptions.Expected resultsThe results from this randomized controlled trial will provide important empirical evidence for the use of mobile phone technology as a tool for improving population-based cancer screening programs. These results may influence the cancer screening invitation procedure in future routine practice.Trial registrationRegistry: NCT04343950 (04/09/2020); clinicaltrials.gov.

A Patient Portal-Based Commitment Device to Improve Adherence with Screening for Colorectal Cancer: a Retrospective Observational Study.

Despite significant investment in colorectal cancer (CRC) screening, 40% of US adults are not up-to-date. Commitment devices, which are psychologically tailored approaches to enforce health goals, may be an effective method to increase CRC screening. Compare the effectiveness of a commitment device (patient self-ordering fecal immunochemical test (FIT) kits) to standard CRC screening outreach. A retrospective observational study. Participants were > 49years and < 75years, had no history of CRC, and were eligible for CRC screening. An electronic screening reminder with an embedded order button allowed participants to order FIT kits directly from a patient portal. Those who used the order button were promptly sent a kit; those who did not were later mailed kits. Primary outcome was completion of FIT kits. Secondary outcomes included number of days to completion, completion of follow-up for positive results, and CRC diagnosis; we also examined prior use of FIT kit. We used inverse probability of treatment weights to control for pretreatment imbalances. The cohort comprised 176,231 participants: 53% female; median age was 59; 11% were Asian, 21% Hispanic/Latino, 7% black, 51% White, 3% other/mixed race. Approximately 10% (N = 16,918) used the button. Using inverse probability of treatment weights, we found that those who used the button had 3.8 times the odds of completing a kit compared to participants who did not (odds ratio, 3.77; 95% confidence interval, 3.57-3.98). Within the button group, 63% of those eligible completed a FIT kit in the year prior to the button compared to 87% in the year after the button became available (p < 0.0001). The ability to self-order screening kits may act as a commitment device that increases CRC screening. Scalable tools leveraging existing patient portals such as this can complement existing CRC outreach strategies.

Role of community pharmacies in a population-based colorectal cancer screening program

In Catalonia (Spain), population-based colorectal cancer (CRC) screening offers biennial fecal occult blood testing to men and women aged 50–69 years old. The program is organized in screening hubs, most of which use a pharmacy-based model to distribute and collect fecal immunochemical test (FIT) kits The comprehensive evaluation of CRC screening programs, which include the role and implications of pharmacy involvement, is essential to ensure program quality and identify areas for further improvement. The present study aimed to assess the adherence of community pharmacies to the CRC screening program and to analyze data on FIT kit distribution and collection in the Metropolitan area of Barcelona (Catalonia, Spain). Time to FIT completion was assessed by Kaplan-Meier estimation, and with the log-rank test. A Cox regression model was used to adjust for other variables associated with the completion of FIT such as sex, age, deprivation score index and previous screening behavior. Overall, 82.4% of pharmacies adhered with CRC screening program. Out of 82,902 FIT kits distributed to screening invitees 77,524 completed FIT kits were returned to pharmacies (93.5%) with a participation of 39.8% among the 193,766 invitees. From those who completed a FIT, the median time to return the kit was 3 days. FIT completion time was significantly lower among women, older age, high deprivation score index and previous CRC screening (p < 0.005). Our findings highlight the large involvement of community pharmacists with CRC screening program as well as a high quality in the process of FIT distribution and collection.

Yield of colorectal cancer at colonoscopy according to faecal haemoglobin concentration in symptomatic patients referred from primary care.

Lower gastrointestinal (GI) symptoms are poor predictors of colorectal cancer (CRC). The aim of this study was to examine the diagnostic yield of colonoscopy by faecal haemoglobin (f-Hb) concentration in symptomatic patients assessed in primary care by faecal immunochemical testing (FIT). In three Scottish NHS Boards, FIT kits (HM-JACKarc, Hitachi Chemical Diagnostics Systems Co., Ltd, Tokyo, Japan) were used by general practitioners to guide referrals for patients with lower GI symptoms (laboratory data studied for 12months from December 2015 onwards in Tayside, 18months from June 2018 onwards in Fife and 5months from September 2018 onwards in Greater Glasgow and Clyde). Cases of CRC diagnosed at colonoscopy were ascertained from colonoscopy and pathology records. Four thousand eight hundred and forty one symptomatic patients who underwent colonoscopy after FIT submission were included. Of the 2166 patients (44.7%) with f-Hb <10µg Hb/g faeces (µg/g), 14 (0.6%) were diagnosed with CRC, with a number needed to scope (NNS) of 155. Of the 2675 patients (55.3%) with f-Hb ≥10µg/g, 252 were diagnosed with CRC (9.4%) with a NNS of 11. Of the 705 patients with f-Hb ≥400µg/g, 158 (22.4%) were diagnosed with CRC with a NNS of 5. Over half of those diagnosed with CRC with f-Hb <10µg/g had coexisting anaemia. Symptomatic patients with f-Hb ≥10µg/g should undergo further investigation for CRC, while higher f-Hb concentrations could be used to triage for urgency during the COVID-19 recovery phase. Patients with f-Hb <10µg/g and without anaemia are very unlikely to be diagnosed with CRC and the majority need no further investigation.

Fecal Immunologic Test Results and Diagnostic Colonoscopy in a Mexican Population at Average Risk for Colorectal Cancer.

Colorectal cancer is preventable and treatable by screening and early detection. Fecal immunochemical tests (FIT) for average risk individuals is an effective strategy for screening. Incidence and mortality in Mexico is increasing and large-scale screening programs do not yet exist. The aim of this study was to evaluate the feasibility of FIT-based colorectal cancer screening program in Mexico City. For more than 15 months, average risk individuals in Mexico City were invited to participate at Mexico's Instituto Nacional de Cancerologia (INCan, Mexico City, Mexico). Participants received an FIT kit for stool collection, results ≥20 ng/mL were referred for high quality colonoscopy. Participants' results were classified according to the most advanced clinical finding as: adenocarcinoma, high-risk adenomas, low-risk adenomas, serrated lesions, hyperplastic polyps, and no polyps. Sequential analyses were performed to assess the positive predictive value (PPV) of FIT. A total of 810 participants were eligible, 737 (91.0%) returned the FIT and 112 (15.2%) had an abnormal result. Of these participants, 87 (77.7%) completed colonoscopy. Clinical findings of participants included: seven (8.1%) adenocarcinomas, 18 (20.7%) high-risk adenomas, 23 (26.4%) low-risk adenomas, one (1.2%) serrated lesions, 14 (16.1%) hyperplasic polyps, and 24 (27.6%) no polyps. The PPV of FIT using the ≥20 ng/mL was 8.1% for cancer and 20.7% for high-risk adenomas. In conclusion, colorectal cancer screening with FIT is feasible at INCan in Mexico City, where resources are available. Further studies are needed to determine feasibility of colorectal cancer screening in other settings, as well as optimal hemoglobin detection cut-off points to maximize the population benefits of colorectal cancer screening with FIT in Mexico.

Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods.

Evidence-based programs such as mailed fecal immunochemical test (FIT) outreach can only affect health outcomes if they can be successfully implemented. However, attempts to implement programs are often limited by organizational-level factors. As part of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) pragmatic trial, we evaluated how organizational factors impacted the extent to which health centers implemented a mailed FIT outreach program. Eight health centers participated in STOP CRC. The intervention consisted of customized electronic health record tools and clinical staff training to facilitate mailing of an introduction letter, FIT kit, and reminder letter. Health centers had flexibility in how they delivered the program. We categorized the health centers' level of implementation based on the proportion of eligible patients who were mailed a FIT kit, and applied configurational comparative methods to identify combinations of relevant organizational-level and program-level factors that distinguished among high, medium, and low implementing health centers. The factors were categorized according to the Consolidated Framework for Implementation Research model. FIT tests were mailed to 21.0-81.7% of eligible participants at each health center. We identified a two-factor solution that distinguished among levels of implementation with 100% consistency and 100% coverage. The factors were having a centralized implementation team (inner setting) and mailing the introduction letter in advance of the FIT kit (intervention characteristics). Health centers with high levels of implementation had the joint presence of both factors. In health centers with medium levels of implementation, only one factor was present. Health centers with low levels of implementation had neither factor present. Full implementation of the STOP CRC intervention relied on a centralized implementation team with dedicated staffing time, and the advance mailing of an introduction letter. ClinicalTrials.gov Identifier: NCT01742065 Registered 05 December 2012-Prospectively registered.