Fecal Immunochemical Test Kit Research Articles

Abstract 594: Strategies to improve repeat CRC screening in rural community clinics using the fecal immunochemical test (FIT)

Abstract Introduction: Colorectal cancer (CRC), the second leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low income individuals, adults with low literacy and those living in rural areas. Objectives: To assess the effectiveness of two health literacy informed telephone follow-up strategies to improve annual repeat screening with Fecal Immunochemical Test (FIT) in rural community clinics. Methods: A two-arm, randomized controlled trial is being implemented in four community clinics. Clinics reported CRC baseline screening rates of 1% to 3%. Eligible patients, age 50-75, were recruited at the clinic prior to a scheduled appointment. A research assistant (RA) conducted a baseline structured interview. The RA then recommended screening and gave brief literacy and culturally appropriate education using a pamphlet (4th grade level), the FIT kit with pre-addressed envelope, simplified instructions (3rd grade level) and a demonstration of how to use it, At four weeks patients who had not returned their kit receive either 1) a personal follow-up call (PC) from a central prevention coordinator using motivational interviewing skills and reminding them to complete and mail FIT kits; or 2) an automated follow-up call (AC) using plain language and motivational messages encourages patients to complete and mail the FIT. During years 2 and 3, FIT kits were mailed to patients along with previous literacy and culturally appropriate education. Follow-up call procedures previously used at weeks 4 and 8 were followed. Results: 620 patients not up-to-date with screening were enrolled; 66% were African American, 55% women; 40% had limited literacy. Screening results: 1st Year Screening: 620 patients enrolled - (6 withdrew before completing test) AC Arm (n=308) 213 (69%) completed kits [23 (7%) positive] 124 (40%) people needed at least one follow-up call [29 (24%) returned FIT after call] PC Arm (n=306) 205 (67%) completed kits [21 (7%) positive] 127 (41%) people needed at least one follow-up call [26 (20%) returned FIT after call] 2nd Year Screening: 568 Second kits mailed (4 withdrew and no previous positives included) AC Arm (n=285) 111 (40%) completed kits [9 (8%) positive] 212 (74%) people needed at least one follow-up call [40 (19%) returned FIT after call]PC Arm (n=283) 104 (37%) completed kits [8 (8%) positive] 209 (74%) people needed at least one follow-up call [31 (15%) returned FIT after call] Discussion: Simplified instructions accompanied by a face-to-face demonstration of FIT, use of “teach back” to confirm understanding with a follow-up call if needed, facilitated completion rates of all patients, particularly those with limited literacy. The less costly and time consuming automated call was equally effective as a personal call. Citation Format: Connie L. Arnold, Terry C. Davis, James Morris, Alfred Rademaker, Glenn Mills. Strategies to improve repeat CRC screening in rural community clinics using the fecal immunochemical test (FIT) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 594.

Abstract B19: Screen to Save (S2S) implementation across National Outreach Network (NON) region 2

Abstract Background: S2S aims to increase colorectal cancer (CRC) screening rates among community members aged 50-75 years from racially and ethnically diverse communities. The National Cancer Institute's (NCI) National Outreach Network (NON) and Partnerships to Advance Cancer Health Equity (PACHE) community health educators (CHEs) are implementing a culturally sensitive, evidence-based nationwide CRC outreach and screening initiative. This poster reports on S2S activities within NON Region 2 among multilingual and multicultural populations. Methods: NCI tasked sites with conducting phase 1 or phase 1 and 2 of S2S. Phase 1 consists of CRC prevention, early detection, and screening education via NCI CRC resources and materials. Phase 2 consists of providing the education and fecal immunochemical test (FIT) kits to those who qualify. Both phases consist of pre- and post-knowledge assessments coupled with demographic information of attendees. A 3-month follow-up survey is administered post the S2S session to determine participants' CRC-screening- related actions. Effective strategies for initiative recruitment include electronic and in-person flyer dissemination, social media postings, and community partner engagement. Colorectal cancer models, a miniature portable toilet, and an NCI-developed S2S PowerPoint presentation have been utilized across the region as educational tools. Results: Four NON and PACHE CHEs in the region are implementing the S2S initiative with the aid of community partnerships. To date, more than 81 individuals have received CRC education through a total of 5 S2S sessions. A total of 66 FIT kits have been disseminated and 16 returned. Conclusion: Lessons learned from this ongoing initiative include the importance of having a multilevel educational approach and collaborations at local, state, and national levels for CRC education and screening. Leveraging partnerships for CRC education and screening is an effective strategy to improve CRC awareness and promote FIT uptake. Citation Format: Khaliah F. Fleming, Jomar D. Lopez. Screen to Save (S2S) implementation across National Outreach Network (NON) region 2 [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr B19.

Abstract A13: Using boot camp translation to design a system-based intervention to improve rates of colon cancer screening using fecal immunochemical testing among Latino patients in community health centers

Abstract Introduction: Colon cancer is the second-leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. In 2015, only 63% of eligible adults, and 50% of Latinos, were up to date with colon cancer screening recommendations. One factor thought to contribute to the low screening rate is that patient-facing health information for Latinos is difficult to understand and patients face challenges in taking appropriate health action. As part of the Participatory Research to Advance Colon Cancer Prevention (PROMPT) study that seeks to raise rates of colon cancer screening in a Latino-serving community health center in California, we used boot camp translation (BCT), a validated community-based participatory strategy, to elicit input from diverse stakeholders and refine the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical test (FIT) program. Methods: We adapted BCT to engage Latino patients and clinic staff in this research. Eligible patient participants were Latino, aged 50 to 75 years, able to speak English or Spanish, and willing to participate in a 6-hour in-person meeting and three 30-minute follow-up phone calls. Materials were developed in English and Spanish, and separate sessions were held for English- and Spanish-speaking participants. As part of the in-person sessions, a national bilingual colon cancer expert delivered a presentation on colon health, cancer screening, and messages to improve screening participation, specific to Latino populations. Following the presentation, BCT experts facilitated brainstorming sessions to obtain feedback on the presented information, followed by an interactive small-group session where participants reviewed sample written materials and reminder messages using various modalities (e.g., text, letter, automated and live calls). We asked participants to consider what information about colon cancer screening is important to share with other patients, what the best methods are to share these messages, and the frequency with which these messages should be delivered to patients to encourage FIT completion. Participants then engaged in a hands-on exercise to share input about the timing and frequency of reminder delivery. Results from the exercise were used to define the intervention for the PROMPT pilot. Results: A total of 25 adults participated in an in-person session (12 in the English-language session; 13 in the Spanish-language session). Participants were mostly clinic patients (84%) and the majority were female (80%). Among the patient participants, 57% were enrolled in Medicaid, and 67% reported an annual household income of less than $20,000. Key themes from the sessions included increasing awareness about colon cancer and screening options, stressing the urgency of screening, and using personalized messages such as “I” statements in letters or human voices on automated phone call reminders. Both sessions noted the importance of receiving an alert (automated or live) before the FIT kit is mailed, and of receiving a reminder within 2 weeks of FIT kit mailing. Conclusions: Our BCT process allowed English- and Spanish-speaking Latino patients to directly inform which approaches get tested in the pilot study by refining message content and selecting their modality and timing to encourage patients who are mailed a FIT to complete it and mail it back. Using BCT, we successfully incorporated participant feedback to design culturally relevant health messages to promote FIT testing among patients served by community clinics. Citation Format: Jamie Thompson, Melinda Davis, LeAnn Michaels, Jennifer Rivelli, Marta Castro, Anne Escaron, Brittany Younger, Melissa Castillo, Sacha Reich, Gloria Coronado. Using boot camp translation to design a system-based intervention to improve rates of colon cancer screening using fecal immunochemical testing among Latino patients in community health centers [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A13.

Abstract B11: Sustaining annual colorectal cancer screening in rural community health clinics using the fecal immunochemical test (FIT)

Abstract Introduction: Colorectal cancer (CRC), the second leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low-income individuals, adults with low literacy, and those living in rural areas. These groups all have screening completion rates below 50%. Objectives: To assess patient knowledge, beliefs, and self-efficacy about CRC screening and compare the effectiveness of two health literacy informed telephone follow-up strategies to improve annual screening over a three-year period with fecal immunochemical test (FIT) in rural community clinics. Methods: A two-arm, randomized controlled trial is being implemented in four community clinics. Clinics reported CRC baseline screening rates of 3% to 5%. Eligible patients, age 50-75, were recruited at the clinic prior to a scheduled appointment. A research assistant (RA) conducted a baseline structured interview measuring CRC screening knowledge, beliefs, and self-efficacy. The RA then recommended screening and gave brief literacy and culturally appropriate education using a pamphlet (4th-grade level), the FIT kit with preaddressed envelope, simplified instructions (3rd-grade level), and a demonstration of how to use it. At four weeks patients who had not returned their kit received either 1) a personal follow-up call (PC) from a central prevention coordinator using motivational interviewing skills and reminding them to complete and mail FIT kits, or 2) an automated follow-up call (AC) using plain language and motivational messages encouraging patients to complete and mail the FIT. Outcomes include FIT completion after intervention, and again at 12 and 24 months. Results: 620 patients not up to date with screening were enrolled: 64% African American, 56% women, 40% inadequate literacy. Although 90% reported having heard of CRC, only 64% knew a test to check for CRC. 70% reported that a provider had recommended CRC screening in the past and 91% reported they would want to know if they have CRC. Self-efficacy was high, with over 90% indicating they would return the kit to the lab. Screening results: 620 patients enrolled (AC: n=308 / PC: n=306); 418 (68%) completed tests (AC: n=213 (69%) / PC: n=205 (67%)). Follow-up calls for unreturned kits--AC: 124 (40%) people called--29 returned FIT (9.4% of people called completed FIT). PC: 127 (41%) people called--26 returned FIT (9.4% of people called completed FIT). 2nd-year screening: 255 second kits mailed out to date (AC: n=128/PC: n=125); 98 (38.5%) completed tests (AC: n=49 (38%) / PC: n=49 (39%)). Follow-up calls for unreturned kits--AC: 89 (70%) people called—19 returned FIT (14.8% of people called completed FIT). PC: 82 (66%) people called—17 returned FIT (13.6% of people called completed FIT). Discussion: Implementing health literacy influenced CRC education, and screening strategies using the FIT and phone reminders dramatically increased FIT completion in rural community clinics. The less costly and time-consuming automated call was equally effective as a personal call. Citation Format: Connie L. Arnold, Terry C. Davis, Alfred Rademaker, James Morris, Glenn Mills. Sustaining annual colorectal cancer screening in rural community health clinics using the fecal immunochemical test (FIT) [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr B11.

Abstract C71: Discrepancies in perceptions of colorectal cancer screening and willingness to screen among Federally Qualified Health Centers staff and Latino community members

Abstract Background: With colorectal cancer (CRC) persisting as the second leading cause of cancer deaths in the US, it is imperative that screening perceptions and behaviors among underserved populations be investigated and better understood. Latinos have exhibited lower rates of maintaining consistent and timely screening measures for CRC: while nearly 61% of non-Hispanic whites are screening regularly for CRC, Latinos fall behind at just below 45%. Federally Qualified Health Centers (FQHCs) attempt to address this disparity by providing outreach and screening services to medically underserved patients. In 2014, approximately 13% of FQHC patients nationwide self-identified as Latino; this underscores this population's need for affordable and tailored care. As the passing of the Affordable Care Act has gradually increased access to health care among Americans who had previously been uninsured, FQHCs have a unique opportunity to implement interventions that target populations and individuals who now have access to regular care. Objective: The purpose of the present study was to identify discrepancies in perceptions of CRC screening and willingness to screen among FQHCs staff and Latino community members living in San Diego, California. In-depth interviews (n=17) were held with health care providers and staff at local FQHCs (mean age: 38.8 years; 64.7% female; 88.2% Latino) and five focus groups (n=39) were conducted with community members who reside in neighborhoods served by FQHCs (mean age: 59.4 years; 79.5% female; 97.4% Latino). Method: Using standardized interview and focus group guides based on Social Ecological Model (SEM), FQHCs staff and community members were asked to describe their experience with CRC screening. Beliefs, attitudes, and perceptions regarding CRC screening and related referrals were also discussed. Interviews and focus groups were audio recorded and transcribed, and content analysis was used to create a codebook based on SEM. Two coders independently reviewed transcripts and applied codes, meeting to resolve inconsistent coding via consensus. Data were summarized according to two themes: 1) patient-level facilitators and barriers to CRC screening and 2) organizational barriers to CRC screening. Results: While patients often reported feeling that they had access to medical information and had a grasp of the basic tenets of preventive health care, FQHCs staff consistently reported a lack of CRC-specific knowledge among patients in their clinics. Community members' reported willingness to screen for CRC was higher than FQHCs staffs' perception of it. FQHCs patients were viewed by staff as being afraid or embarrassed to screen, while community members generally reported feeling comfortable with CRC screening methods. FQHCs staff identified organizational barriers, such as the fragmentation of the referral process and a lack of knowledge of appropriate screening procedures. Organizational facilitators at FQHCs were also identified, including the option of mailing completed fecal immunochemical tests (FIT) to labs as well as the overall cohesion and organizational capacities of the FQHCs' Electronic Health Record systems. Additionally, FQHCs staff reported having implemented a pilot program that sought to aid patients in understanding the importance and processes of using the FIT kit as well as facilitating the completion and return of FIT tests. Discussion: The present study's findings suggest FQHCs staff may lack confidence in their patients' abilities and knowledge in obtaining CRC screening. Several discrepancies were noted with regard to patients' willingness and ability to obtain CRC screening. Interventions that work to improve communication between FQHC staff and patients would be beneficial to the Latino populations living in this region. Citation Format: Elizabeth N. Alpert, Sumayah Nuhaily, Carolina López De la Torre, Jessica Haughton, Samir Gupta, Jesse Nodora, Balambal Bharti, Christian Ramers, Felipe Garcia, Tatianna Clark, Claudia Carrizosa, Elva M. Arredondo, Kristen J. Wells. Discrepancies in perceptions of colorectal cancer screening and willingness to screen among Federally Qualified Health Centers staff and Latino community members [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr C71.

Balancing Adherence and Expense: The Cost-Effectiveness of Two-Sample vs One-Sample Fecal Immunochemical Test.

Colorectal cancer (CRC) causes more than 50,000 deaths each year in the United States but early detection through screening yields survival gains; those diagnosed with early stage disease have a 5-year survival greater than 90%, compared to 12% for those diagnosed with late stage disease. Using data from a large integrated health system, this study evaluates the cost-effectiveness of fecal immunochemical testing (FIT), a common CRC screening tool. A probabilistic decision-analytic model was used to examine the costs and outcomes of positive test results from a 1-FIT regimen compared with a 2-FIT regimen. The authors compared 5 diagnostic cutoffs of hemoglobin concentration for each test (for a total of 10 screening options). The principal outcome from the analysis was the cost per additional advanced neoplasia (AN) detected. The authors also estimated the number of cancers detected and life-years gained from detecting AN. The following costs were included: program management of the screening program, patient identification, FIT kits and their processing, and diagnostic colonoscopy following a positive FIT. Per-person costs ranged from $33 (1-FIT at 150ng/ml) to $92 (2-FIT at 50ng/ml) across screening options. Depending on willingness to pay, the 1-FIT 50 ng/ml and the 2-FIT 50 ng/ml are the dominant strategies with cost-effectiveness of $11,198 and $28,389, respectively, for an additional AN detected. The estimates of cancers avoided per 1000 screens ranged from 1.46 to 4.86, depending on the strategy and the assumptions of AN to cancer progression.

Performance of a quantitative fecal immunochemical test for detecting advanced colorectal neoplasia: a prospective cohort study

BackgroundThe fecal immunochemical test (FIT) is easier to use and more sensitive than the guaiac fecal occult blood test, but it is unclear how to optimize FIT performance. We compared the sensitivity and specificity for detecting advanced colorectal neoplasia between single-sample (1-FIT) and two-sample (2-FIT) FIT protocols at a range of hemoglobin concentration cutoffs for a positive test.MethodsWe recruited 2,761 average-risk men and women ages 49-75 referred for colonoscopy within a large nonprofit, group-model health maintenance organization (HMO), and asked them to complete two separate single-sample FITs. We generated receiver-operating characteristic (ROC) curves to compare sensitivity and specificity estimates for 1-FIT and 2-FIT protocols among those who completed both FIT kits and colonoscopy. We similarly compared sensitivity and specificity between hemoglobin concentration cutoffs for a single-sample FIT.ResultsDifferences in sensitivity and specificity between the 1-FIT and 2-FIT protocols were not statistically significant at any of the pre-specified hemoglobin concentration cutoffs (10, 15, 20, 25, and 30 μg/g). There was a significant difference in test performance of the one-sample FIT between 50 ng/ml (10 μg/g) and each of the higher pre-specified cutoffs. Disease prevalence was low.ConclusionsA two-sample FIT is not superior to a one-sample FIT in detection of advanced adenomas; the one-sample FIT at a hemoglobin concentration cutoff of 50 ng/ml (10 μg/g) is significantly more sensitive for advanced adenomas than at higher cutoffs. These findings apply to a population of younger, average-risk patients in a U.S. integrated care system with high rates of prior screening.

Identifying quality improvement targets to facilitate colorectal cancer screening completion.

The colorectal cancer (CRC) screening process involves multiple interfaces (communication exchanges and transfers of responsibility for specific actions) among primary care and gastroenterology providers, laboratory, and administrative staff. After a retrospective electronic health record (EHR) analysis discovered substantial clinic variation and low CRC screening prevalence overall in an urban, integrated safety-net system, we launched a qualitative analysis to identify potential quality improvement targets to enhance fecal immunochemical test (FIT) completion, the system's preferred screening modality. Here, we report examination of organization-, clinic-, and provider-level interfaces over a three-year period (December 2011–October 2014).We deployed in parallel 3 qualitative data collection methods: (1) structured observation (90+ hours, 10 sites); (2) document analysis (n > 100); and (3) semi-structured interviews (n = 41) and conducted iterative thematic analysis in which findings from each method cross-informed subsequent data collection. Thematic analysis was guided by a conceptual model and applied deductive and inductive codes.There was substantial variation in protocols for distributing and returning FIT kits both within and across clinics. Providers, clinic and laboratory staff had differing access to important data about FIT results based on clinical information system used and this affected results reporting. Communication and coordination during electronic referrals for diagnostic colonoscopy was suboptimal particularly for co-morbid patients needing anesthesia clearance.Our multi-level approach elucidated organizational deficiencies not evident by quantitative analysis alone. Findings indicate potential quality improvement intervention targets including: (1) best-practices implementation across clinics; (2) detailed communication to providers about FIT results; and (3) creation of EHR alerts to resolve pending colonoscopy referrals before they expire.

Colorectal Cancer: A Collaborative Approach to Improve Education and Screening in a Rural Population .

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and second leading cause of cancer death for men and women in the United States. Although early detection and diagnosis greatly affect survival rates, only about half of the U.S. population participates in screening. . The purpose of this project was to implement community-based CRC education and screening. Outcomes included CRC knowledge, CRC screening kit return rate, and rate of positive screening results. . Partnering with a community hospital, CRC educational sessions and free screening opportunities were provided for 193 local city government employees. CRC knowledge was assessed before and after education with the Knowledge Assessment Survey. A paired t test indicated significant improvement in mean CRC knowledge. . More than half of the participants elected to take home fecal immunochemical test kits. Of the 29 participants who submitted their screening kits for evaluation, eight had positive results and received referral recommendations. All participants were notified of their screening results. The community-based CRC project was effective in improving CRC knowledge and screening participation.

The NHS Bowel Cancer Screening Program: current perspectives on strategies for improvement.

Colorectal cancer (CRC) is the third most common cancer in the UK. The English National Health Service (NHS) Bowel Cancer Screening Program (BCSP) was introduced in 2006 to improve CRC mortality by earlier detection of CRC. It is now offered to patients aged 60–74 years and involves a home-based guaiac fecal occult blood test (gFOBt) biennially, and if positive, patients are offered a colonoscopy. This has been associated with a 15% reduction in mortality. In 2013, an additional arm to BCSP was introduced, Bowelscope. This offers patients aged 55 years a one-off flexible sigmoidoscopy, and if several adenomas are found, the patients are offered a completion colonoscopy. BCSP has been associated with a significant stage shift in CRC diagnosis; however, the uptake of bowel cancer screening remains lower than that for other screening programs. Further work is required to understand the reasons for nonparticipation of patients to ensure optimal uptake. A change of gFOBt kit to the fecal immunochemical tests (FIT) in the English BCSP may further increase patient participation. This, in addition to increased yield of neoplasia and cancers with the FIT kit, is likely to further improve CRC outcomes in the screened population.

Abstract 770: Colorectal cancer screening in rural community health clinics using the fecal immunochemical test (FIT)

Abstract Introduction: Colorectal cancer (CRC), the second leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low income individuals, adults with low literacy and those living in rural areas. These groups all have screening completion rates below 50%. Objectives: To assess patient knowledge, beliefs, and self-efficacy about CRC screening and compare the effectiveness of two health literacy informed telephone follow-up strategies to improve initial and annual repeat screening with Fecal Immunochemical Test (FIT) in rural community clinics. Methods: A two-arm, randomized controlled trial is being implemented in four community clinics. Clinics reported CRC baseline screening rates of 1% to 3%. Eligible patients, age 50-75, are recruited at the clinic prior to a scheduled appointment. A research assistant (RA) conducts a baseline structured interview measuring CRC screening knowledge, beliefs, and self-efficacy. The RA then recommends screening and gives brief literacy and culturally appropriate education using a pamphlet (4th grade level), the FIT kit with pre-addressed envelope, simplified instructions (3rd grade level) and a demonstration of how to use it, At four weeks patients who have not returned their kit receive either 1) a personal follow-up call (PC) from a central prevention coordinator using motivational interviewing skills and reminding them to complete and mail FIT kits; or 2) an automated follow-up call (AC) using plain language and motivational messages encourages patients to complete and mail the FIT. Outcomes include FIT completion after intervention, and again at 12 and 24 months. 650 patients will be enrolled. Results: To date 599 patients not up-to-date with screening have been enrolled; 64% African American, 56% women; 40% inadequate literacy. Although 90% reported having heard of CRC, only 64% knew a test to check for CRC. 70% reported a provider had recommended CRC screening in the past and 91% reported they would want to know if they have CRC. Self-efficacy was high with over 90% indicating they would return the kit to the lab. Screening results: 599 patients enrolled to date (AC: n=300 / PC: n=299); 412 (69%) completed tests (AC: n=210 (70%) / PC: n=202 (68%)). Follow-up calls for Unreturned Kits - AC: 113 people called - 26 returned FIT (23% of people called completed FIT). PC: 115 people called - 22 returned FIT - (19% of people called completed FIT). 2nd Year Screening: 129 Second kits mailed out to-date. AC (n=61): n=29 (48%) completed kits. PC (n=68): 28 (41%) completed kits. Discussion: Implementing literacy and culturally appropriate CRC education and screening strategies using the FIT and phone reminders has the potential to increase CRC screening rural community clinics and address public health disparities. Citation Format: Connie L. Arnold, Terry C. Davis, Alfred W. Rademaker, James Morris, Glenn Mills. Colorectal cancer screening in rural community health clinics using the fecal immunochemical test (FIT) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 770. doi:10.1158/1538-7445.AM2017-770

Evaluating Two Evidence-Based Intervention Strategies to Promote CRC Screening Among Latino Adults in a Primary Care Setting.

Regular use of colorectal cancer screening can reduce incidence and mortality, but participation rates remain low among low-income, Spanish-speaking Latino adults. We conducted two distinct pilot studies testing the implementation of evidence-based interventions to promote fecal immunochemical test (FIT) screening among Latinos aged 50-75years who were not up-to-date with CRC screening (n=200) at a large Federally Qualified Health Center (FQHC) in San Diego, CA. One pilot focused on an opportunistic clinic visit "in-reach" intervention including a 30-min session with a patient navigator, review of an educational "flip-chart," and a take-home FIT kit with instructions. The second pilot was a system-level "outreach" intervention consisting of mailed materials (i.e., FIT kit, culturally and linguistically tailored instructions, and a pre-paid return envelope). Both received follow-up calls to promote screening completion and referrals for additional screening and treatment if needed. The primary outcome was FIT kit completion and return within 3months assessed through electronic medical records. The in-reach pilot consisted of mostly insured (85%), women (82%), and Spanish-speaking (88%) patients. The outreach pilot consisted of mostly of Spanish-speaking (73%) women (64%), half of which were insured (50%). At a 3-month follow-up, screening completion was 76% for in-reach and 19% for outreach. These data demonstrate that evidence-based strategies to promote CRC screening can be implemented successfully within FQHCs, but implementation (particularly of mailed outreach) may require setting and population-specific optimization. Patient, provider, and healthcare system related implementation approaches and lessons learned from this study may be implemented in other primary care settings.

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team.

Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic's overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it.

Abstract A29: Disseminating colorectal cancer screening guidelines in Asian-American communities using a market-oriented and multilevel approach

Abstract BACKGROUND There was a significant increase in colorectal cancer (CRC) screening rates in the U.S. population between 2008 and 2010; however, Asian Americans (AA) remained the only racial/ethnic subgroup without any improvement and was at 47%. Therefore, accelerating the dissemination and adoption of CRC screening guidelines in the AA communities has the potential to reduce unnecessary cancer burden. The traditional top-down dissemination model views communities as passive distribution or delivery systems rather than as rich sources of knowledge and skills and dynamic places in which prevention programs will ultimately need to survive and thrive. In this study, we developed a community-centered dissemination model using a multilevel approach to accelerate the adoption of CRC screening guidelines in seven Asian communities. METHODS We integrated a market-oriented Push-Pull-Infrastructure framework with Diffusion of Innovation Theory, and Community-Based Participatory Research (CBPR) to create a community-centered dissemination model. Community focus groups were conducted to identify salient CRC screening beliefs and attitudes, and were used to develop survey measures to more broadly sample community residents. Findings from the survey were used to develop both training content for community outreach and tailored social marketing campaigns for our intervention. The seven partner AA communities were randomly divided into two cohorts. A wait-list cross-over random design was used to evaluate the effectiveness of our outreach intervention. Primary outcomes included educational session attendance, Fecal Immunochemical Test (FIT) kits distribution and returned rates. Data were collected over three different time periods. RESULTS Collaboration took place between an academic institution and eight community-based organizations from seven Asian subgroups (Cambodian, Chinese, Filipinos, Korean, Laotian, South Asians and Vietnamese). A sample of 72 AAs participated in focus groups, and differences were noted across ethnic subgroups. Furthermore, 464 community members participated in a community-wide survey. Most participants agreed that early detection of cancer was important (94%) and cancer could happen to anyone (87%). However, 36% of participants also felt that people were better off not knowing they had cancer, and 46% would screen only when they had symptoms. Outreach activities included distribution of printed educational materials, one-on-one counseling and group education. Across the seven communities, ten community health advisors reached out to over 2,400 community residents over a 12-week intervention period. In cohort 1, 148 people attended the post-intervention education session where no-cost FIT kit was offered compared to 17 people at baseline; while in cohort 2, 101 people attended the post-intervention session compared to 27 at baseline. The screening rates for cohort 1 and 2 were 63% (93/148) and 57% (58/101), respectively. Community screening rates ranged from 100% in Cambodian, 89% in Vietnamese and 84% in Chinese, to 42% in Korean and Filipinos, and 32% in South Asians. After an intensive 12-week outreach activity and social marketing campaigns, significant increase was observed in attendance (p = .010), FIT kits distributed (p = .008) and returned (p = .014) compared to baseline data. A cross-over effect was observed. CONCLUSION There is a limited research base to inform the design of successful action plans for dissemination and implementation CRC screening guidelines, especially in underserved populations. Our new model outlines a complementary role for researchers and community-based organizations, focuses on understanding potential adopters and incorporates social interaction and influence to move individuals from simple awareness to decisions towards positive action. Citation Format: Karen Kim, Mike Quinn, Edwin Chandrasekar, Reena Patel, Helen Lam. Disseminating colorectal cancer screening guidelines in Asian-American communities using a market-oriented and multilevel approach. [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 A29.

Abstract A63: Changes in health beliefs among medically-underserved patients enrolled in a community-based randomized controlled trial to promote colorectal cancer screening

Abstract 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.

Abstract A25: A culturally-linguistically salient intervention to increase fecal immunochemical test uptake among Spanish-preferring Latino adults receiving care in community-based clinics

Abstract Background: Among Latinos in the US, colorectal cancer (CRC) is the third leading cause of cancer-related deaths. Despite the benefits of colorectal cancer screening (CRCS) being well recognized, screening is underutilized among Latino adults, ages 50-75. The availability of language and literacy appropriate educational information paired with an accessible, easy-to-use screening tool, such as fecal immunochemical test (FIT), within community health settings is a promising way to impact cancer-related disparities for Spanish-preferring Latino older adults. Formative qualitative efforts (focus groups, key informant interviews, and learner verification interviews) produced a culturally, and linguistically salient photonovella booklet and DVD titled, Latinos Colorectal Cancer Awareness, Research, Education and Screening (CARES). Purpose: This pilot study compared the efficacy of two intervention conditions on FIT uptake among Spanish-preferring Latino adults receiving care in community clinics. Participants were randomized to receive either the Latinos CARES intervention + FIT or CDC Brochure + FIT. We report preliminary findings at 6 months. Methods: Participants (N=76) were Latinos, accessing care at community-based clinics, prefer to receive their health information in Spanish, aged 50-75, at average CRC risk, and non-adherent to CRCS guidelines. Consented participants were administered a baseline interview assessing awareness of CRCS tests, preventive health model constructs, health literacy (consisting of two validated items), eHealth literacy (eHEALS), and sociodemographic variables. Following the baseline questionnaire, participants were randomized (1:1 allocation) to receive Latinos CARES intervention + FIT or CDC Brochure + FIT. The primary outcome was FIT kit screening uptake at 6 months. Results: Participants were mostly female (67.8%), median age of 55, with less than a High school diploma (61.8%), annual income of less than $10,000 (48.7%), no medical insurance (75.0%), were unemployed or retired (45.3%), self-identified as “other” for race (67.1%), and born in a country other than the US (93.4%). For those born outside the US, the mean number of years spent in the US was 23.4 years. No significant differences on baseline characteristics were found between study conditions. Accrual rate was an average 11 participants per month for 7 months. To date, FIT uptake is 87% (for both groups), a rate that exceeds the Healthy People 2020 goal of 70.5%. One participant with abnormal FIT results was referred for a colonoscopy. Results of participant's colonoscopy indicated cancer was not present. Conclusions: Providing educational materials (print and/or video), coupled with a FIT kit to Spanish-preferring Latinos receiving care in community clinics may be a promising strategy to bolster CRC screening uptake. The successful accrual rate is reflective of a high interest for education on CRCS among Spanish-preferring Latinos. Three-month follow-up for post-intervention assessments on awareness of CRCS tests, preventive health model constructs, and intervention use is currently underway, and assessment of intervention group differences is pending. Although preliminary, the high overall screening uptake among both study conditions far exceeds national targets and provides evidence to move to a larger scale RCT. Citation Format: Enmanuel Antonio Chavarria, Rania Abdulla, Liliana Gutierrez, Lynne Klasko, Dinorah Martinez Tyson, Claudia Aguado Loi, Julian Sanchez, Cathy Meade, Clement Gwede. A culturally-linguistically salient intervention to increase fecal immunochemical test uptake among Spanish-preferring Latino adults receiving care in community-based clinics. [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 A25.

Abstract A15: Using the RE-AIM framework to evaluate a community-based participatory project

Abstract Background There are many situations where randomization control trial is not feasible. Interventions that can be adopted, delivered broadly, consistently implemented, and sustained over time are important to public health, as well as population health research. The RE-AIM framework evaluates interventions in five dimensions (reach, efficacy, adoption, implementation, and maintenance) providing an alternation. The purpose of this study was to demonstrate the feasibility of using the RE-AIM framework to evaluate the effectiveness and sustainability of a community-based participatory (CBPR) project to improve the adoption of colorectal cancer (CRC) screening guidelines in seven Asian American (AA) communities. Method This project consisted of three phases. Phase 1 focused on assessing community organizations' capacity and readiness for the project, as well as conducting consumer research (focus group and survey) to understand the adopters. Phase 2 was the implementation of a multilevel and multicomponent intervention. The intervention included using social marketing campaigns at the community level to generate public awareness and the use of community health advisors (CHAs) for social influence at the individual level. All CHAs were received a 6 –hour training course and a 3-hour refreshed course. Phase 3 was to evaluate the effectiveness of the project using the RE-AIM framework. Both quantitative and qualitative data were collected before, during and after the intervention period. Qualitative data were collected through weekly activity logs, site visits notes, focus groups with implementation CHAs and in-depth interviews with organizational level leaderships. Quantitative data were collected through reports and community resident survey. Seven communities (Cambodian, Chinese, Filipino, Korean, Laotian, South Asians and Vietnamese) were involved in Phase 2 and were randomized to two cohorts. A wait-list cross-over random design was used to evaluate the effectiveness of the intervention. Primary outcomes included educational session attendance, Fecal Immunochemical Test (FIT) kits distribution and returned rates. Data were collected over three different time periods. Results Of the eight community-based organizations that joined the project, seven of them agreed to participate in Phase 2. Across the seven communities, ten CHAs reached out to over 2,400 community residents over a 12-week intervention period. No significant deviation or inconsistency of delivery across program components was found during site visits. Project satisfaction rates were high, ranging from 8 to 10 out of a 10 point scale (0=not at all satisfy and 10 = extremely satisfy). Screening rates for cohort 1 and 2 were 63% (93/148) and 57% (58/101), respectively. Community screening rates ranged from 100% in Cambodian, 89% in Vietnamese and 84% in Chinese, to 42% in Korean and Filipinos, and 32% in South Asians. After the 12-week intervention period, significant increase was observed in education session attendance (p = .010), FIT kits distributed (p = .008), and returned (p = .014) compared to baseline data. A cross-over effect was observed. Leaderships reported the project addressed organizations' mission, and aligned with their values and priorities. All sites indicated that they would continue to promote CRC screening as part of their health program. Conclusion The RE-AIM framework is crucial in evaluating community-based projects when randomized control trial is infeasible. Each RE-AIM dimension is an opportunity for future improvement and intervention. Partial or all dimensions can be addressed within a given study, but they are not necessary to be intervened upon. RE-AIM evaluation can increase transparency and help potential adopters to make more informed judgement about the intervention and its applicability. Citation Format: Helen Lam, Michael Quinn, Edwin Chandrasekar, Karen Kim. Using the RE-AIM framework to evaluate a community-based participatory project. [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 A15.

A randomized controlled trial of a multicomponent, targeted, low-literacy educational intervention compared with a nontargeted intervention to boost colorectal cancer screening with fecal immunochemical testing in community clinics.

The objective of the current study was to improve colorectal cancer (CRC) screening uptake with the fecal immunochemical test (FIT). The current study investigated the differential impact of a multicomponent, targeted, low-literacy educational intervention compared with a standard, nontargeted educational intervention. Patients aged 50 to 75 years who were of average CRC risk and not up-to-date with CRC screening were recruited from either a federally qualified health center or a primary care community health clinic. Patients were randomized to the intervention condition (targeted photonovella booklet/DVD plus FIT kit) or comparison condition (standard Centers for Disease Control and Prevention brochure plus FIT kit). The main outcome was screening with FIT within 180 days of delivery of the intervention. Of the 416 participants, 54% were female; the participants were racially and ethnically diverse (66% white, 10% Hispanic, and 28% African American), predominantly of low income, and insured (the majority had county health insurance). Overall, the FIT completion rate was 81%, with 78.1% of participants in the intervention versus 83.5% of those in the comparison condition completing FIT (P = .17). In multivariate analysis, having health insurance was found to be the primary factor predicting a lack of FIT screening (adjusted odds ratio, 2.10; 95% confidence interval, 1.04-4.26 [P = .04]). The multicomponent, targeted, low-literacy materials were not found to be significantly different or more effective in increasing FIT uptake compared with the nontargeted materials. Provision of a FIT test plus education may provide a key impetus to improve the completion of CRC screening. The type of educational material (targeted vs nontargeted) may matter less. The findings of the current study provide a unique opportunity for clinics to adopt FIT and to choose the type of patient education materials based on clinic, provider, and patient preferences. Cancer 2017;123:1390-1400. © 2016 American Cancer Society.

Fecal Immunochemical Test (FIT) for Colon Cancer Screening: Variable Performance with Ambient Temperature.

Fecal immunochemical tests (FITs) are widely used in colorectal cancer (CRC) screening, but hemoglobin degradation, due to exposure of the collected sample to high temperatures, could reduce test sensitivity. We examined the relation of ambient temperature exposure with FIT positivity rate and sensitivity. This was a retrospective cohort study of patients 50 to 75 years in Kaiser Permanente Northern California's CRC screening program, which began mailing FIT kits annually to screen-eligible members in 2007. Primary outcomes were FIT positivity rate and sensitivity to detect CRC. Predictors were month, season, and daily ambient temperatures of test result dates based on US National Oceanic and Atmospheric Administration data. Patients (n = 472,542) completed 1,141,162 FITs. Weekly test positivity rate ranged from 2.6% to 8.0% (median, 4.4%) and varied significantly by month (June/July vs December/January rate ratio [RR] = 0.79, 95% confidence interval [CI], 0.76 to 0.83) and season. FIT sensitivity was lower in June/July (74.5%; 95% CI, 72.5 to 76.6) than January/December (78.9%; 95% CI, 77.0 to 80.7). FITs completed during high ambient temperatures had lower positivity rates and lower sensitivity. Changing kit design, specimen transportation practices, or avoiding periods of high ambient temperatures may help optimize FIT performance, but may also increase testing complexity and reduce patient adherence, requiring careful study.

Community-Based Colorectal Cancer Screening in a Rural Population: Who Returns Fecal Immunochemical Test (FIT) Kits?

To determine the return rate of community-delivered fecal immunochemical test (FIT) kits in a rural population and to identify significant predictors of returning kits. Residents were recruited in 8 rural Kentucky counties to enroll in the study and receive an FIT kit. Of 345 recruited, 82.0% returned an FIT kit from the point of distribution. These participants were compared to the remainder relative to age, sex, marital status, having an annual income below $15,000, not graduating from high school, not having a regular health care provider, not having health care coverage, being a current smoker, indicating current overweight or obese status, and a scale measure of fatalism pertaining to colorectal cancer. Predictors achieving significance at the bivariate level were entered into a stepwise logistic regression model to calculate adjusted OR and 95% CI. The return rate was 82.0%. In adjusted analyses, those indicating an annual income of less than $15,000 were 2.85 times more likely to return their kits (95% CI: 1.56-5.24; P < .001). Also, those not perceiving themselves to be overweight/obese were 1.95 times more likely to return their kits (95% CI: 1.07-3.55; P = .029). An outreach-based colorectal cancer screening program in a rural population may yield high return rates. People with annual incomes below $15,000 and those not having perceptions of being overweight/obese may be particularly likely to return FIT kits.