A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center
Phase: NA
Conditions: Colorectal Cancer
Sponsor: University of California, San Diego

A RCT of Outreach and Inreach Strategies for Boosting 
CRC Screening in a Federally-Qualified Health Center
NCT02870049
Document Date: 09/01/2015

SPECIFIC AIMS 
Colorectal cancer (CRC) screening has the potential to save lives, but is underutilized, particularly among 
underserved populations. For example, screening rates among Latinos are just 40%, and among uninsured 
and those insured by Medicaid are just 20 and 25%, respectively. Low rates for Latinos are of particular 
concern, as they have higher than average stage at presentation and stage-specific mortality than non-Latino 
whites. To reduce CRC disparities, interventions to optimize screening among underserved populations, 
particularly among Latinos, are required. Federally Qualified Community Health Centers (FQHCs) are in a 
unique position to leverage their service to underserved populations to deliver the benefits of CRC screening 
for several reasons. FQHCs traditionally serve the uninsured, underinsured, and racial/ethnic minorities that 
have traditionally low rates of being up-to-date with cancer screening, and are now required to publically report 
screening rates due to federal mandates. For example, San Ysidro Health Center, Inc. (SYHC) is a large 
FQHC that includes a network of 10 clinic sites that serves over 90,000 patients annually, who come from a 
predominantly low-income, Spanish-speaking Latino population in the U.S.-Mexico border region of San Diego 
County; in 2013 the publicized CRC screening rate was just 31%. While low rates of screening at FQHCs such 
as SYHC are of great concern, provisions within the Affordable Care Act, such as new access to health 
insurance for populations that commonly utilize FQHCs, may offer a historic opportunity to develop and 
implement strategies for optimizing screening rates for underserved populations, including low income Latinos. 
In 2013, SYHC approached UCSD and SDSU partners on how to build a CRC screening infrastructure to 
increase screening rates.   
Despite potential opportunities to deliver screening for underserved populations through FQHCs, many 
challenges exist.  Available strategies for screening promotion have undergone limited development and 
evaluation among low income predominantly Spanish-speaking FQHC Latinos patients. Further, it is unclear 
which strategies are best for increasing screening, and whether implementing multiple approaches (e.g. 
inreach delivered at point of a medical visit vs. outreach not requiring an in-person visit) would be superior to 
taking one approach alone for optimizing screening rates. To begin to address these challenges, we have 
conducted pilot work that has 1) established an academic-community CRC partnership between UCSD, SDSU, 
and SYHC; 2) established that FQHCs are keenly interested in understanding the best and most practical 
strategies for screening promotion; 3) identified (through key informant interviews of providers, clinic 
leadership, experienced promotoras (community health workers), and screening experts) key themes our 
interventions must address; 4) adapted previous effective materials used for mailed FIT outreach and patient 
navigation-based in-reach for screening promotion. Now, utilizing this comprehensive partnership and pilot 
work, we propose the following specific aims: 
Aim 1: Among 648 Latinos age 50-75 years served by the SYHC FQHC, not up-to-date with screening, 
compare impact of 4 strategies on screening completion via a randomized controlled trial. The 
strategies will include: a) a patient-navigation-based, in clinic, inreach strategy, b) a mailed FIT 
outreach strategy (FIT outreach), c) inreach + FIT outreach, and d) usual care (n=162 per group). 
Hypothesis 1a: The inreach strategy (with or without FIT outreach) will be significantly superior to usual care 
Hypothesis 1b: FIT outreach (with or without the inreach strategy) will be significantly superior to usual care 
Hypothesis 1c: FIT outreach + the inreach strategy will be significantly superior to either strategy alone 
compared to usual care. 
Aim 2: Conduct a process evaluation to examine the interventions’ reach, effectiveness, acceptability, 
feasibility, and sustainability following the RE-AIM framework. 
The proposed research is innovative because it seeks to identify pragmatic interventions required to optimize 
CRC screening in a Latino underserved population, is highly feasible, and, will allow us to determine whether a 
combination of outreach and inreach interventions are superior to either strategy alone for increasing CRC 
screening. Further, the community-based partnership approach of linking our academic medical center/NCI-
designated comprehensive cancer center (UCSD), a research university/Hispanic-serving institution (SDSU), 
and a large community health center (SYHC) may serve as a model for developing and implementing 
evidence-based interventions for traditionally underserved populations. Indeed, successful interventions will be 
Demonstration of intervention effectiveness will support adoption by the SYHC, and disseminated through the 
local, regional and national CHC networks (e.g., Council of Community Clinics, California Primary Care 
Association, and the National Association for Community Health Centers). Overall, the research has potential 
to reduce cancer disparities among Latinos and other underserved populations served by FQHCs and beyond. 

	  
RESEARCH PLAN 
 
SIGNIFICANCE 
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States (US). CRC 
accounts for over 136,000 new cancer diagnoses, and over 50,000 deaths annually (1).   
 
Screening can reduce CRC incidence and mortality, but is underutilized, particularly among 
underserved populations. Randomized trials and observational studies have demonstrated that screening 
with fecal occult blood testing (including the guaiac fecal occult blood test (gFOBT) and the fecal 
immunochemical test (FIT)), sigmoidoscopy, and colonoscopy can reduce CRC incidence and mortality (2-7). As 
a result, the US Preventive Services Task Force has recommended screening for all individuals after age 50 
years. However, according to the National Health Interview Survey (NHIS) the national screening rate is 59%, 
far below the 70% Health People 2020 target (8). Moreover, screening rates are particularly low among 
underserved populations, such as Native Americans, Asians, Latinos, individuals living in rural areas, 
individuals with lower education and/or socioeconomic position, and the under-/uninsured (9). For example, the 
screening rate among the uninsured is just 21% (10, 11). 
 
Latinos are at particularly high risk for suboptimal screening, as well as adverse outcomes when CRC 
is diagnosed. Among male and female Latinos combined, CRC is the 2nd leading cause of cancer death, with 
lifetime risk ranging from 4 to 5% (12). Yet the national screening rate among Latinos is just 47%. Additionally, 
Latinos are more likely to be among the uninsured, the group with the lowest overall screening rates (13, 14). 
Compared to non-Latino whites, Latinos are more likely to be diagnosed at advanced stage (15), and less likely 
to survive CRC after diagnosis (12). Thus, because Latinos are the largest and fastest growing ethnic population 
in the US, strategies for increasing CRC screening and survival are required.  
 
Barriers to screening among Latinos include lack of knowledge and awareness, access to care, 
insurance status, language barriers, culture-bound beliefs, and low literacy (16). Research along the 
Texas-Mexico border showed Latinos held misconceptions about CRC, including confusing CRC with prostate, 
stomach, and other cancers. Many had never heard of CRC or CRC screening tests (17). Cancer education 
interventions, such as the use of print materials, have been used to overcome these barriers and increase 
participation in CRC screening (18, 19) in the general population, however, it is unclear whether more culturally-
appropriate intervention strategies are as effective in promoting CRC knowledge among Latinos. 
 
Successful organized strategies to increase screening among underserved populations (including 
Latinos) may involve inreach and outreach approaches. Organized screening requires an “explicit policy in 
a defined target population with a defined implementation and quality assurance structure, and tracking of 
cancer in the population.”(9, 20) Organized screening strategies may broadly categorized as inreach vs. outreach 
based on whether health care visits are required to deliver screening invitations (9).  Inreach strategies promote 
screening at point of routine medical care. Outreach strategies target all eligible individuals within a defined 
population regardless of scheduled health care visits. Inreach strategies take advantage of in-person 
encounters with age-eligible individuals, but may be limited in reach due to requirement for health system 
visits, as many individuals do not access health care on a regular basis. Further, resources required to 
implement inreach strategies to promote screening among all eligible individuals may be substantial. Outreach 
strategies have the advantage of reaching a greater proportion of the population, with a centralized, potentially 
smaller team, but in theory might be less effective than interventions that occur in context of a face-to-face 
healthcare visit. 
 
Examples of successful inreach approaches have included provider assessment and feedback, one-
on-one education, patient navigation to promote colonoscopy completion after referral, and offering 
gFOBT or FIT at time of flu vaccination (21-27). In a single SYHC clinic, we previously piloted delivery of one-
on-one patient education for Latino patients using a culturally linguistically tailored CRC self-help brochure 
containing information on risk factors, knowledge, culture-bound myths and screening tests, with and without 
scripted review of key points within the brochure by a community health advisor prior to a primary care visit (28). 
Compared to usual care, the brochure increased screening knowledge, and also increased frequency of 
discussion of screening with providers by 20%, but no differences were noted between delivery of the brochure 
with or without intense review. These results complement prior work that has shown one-on-one education to 
be effective in promoting screening (21). The main limitations of our prior work include small sample size (n=130 
completed pre and post intervention surveys) and use of a surrogate outcome (knowledge rather than 

	  
screening completion). Additionally, our inreach intervention did not include navigation(22, 23) (such as telephone 
follow up to promote screening completion), and was not supplemented by offers to complete screening at time 
of flu vaccination (24-27, 29), both of which have been shown effective for promoting screening. Whether one or 
both of these approaches might be an effective adjunct to one on one education in the FQHC is unknown, but 
highly relevant given that each of these strategies requires substantial resource investment to implement. We 
postulate that in the FQHC setting, the ideal inreach intervention would be tailored to the local clinic context 
and community needs based on formative research in which we work with patients, providers, and health 
system leaders to determine the most acceptable and practical inreach interventions that can leverage usual 
care medical visits for screening promotion.   
 
Examples of successful outreach approaches have included use of mailed invitations with telephone 
follow up to promote screening fecal occult blood test (FOBT) completion, as well as patient navigation 
to promote colonoscopy completion. We conducted a randomized, comparative effectiveness trial of the 
impact three system-level strategies—usual care, mailed invitation to complete free colonoscopy, and mailed 
invitation to use and return an enclosed fecal immunochemical test FOBT (FIT) kit—among a racially- and 
ethnically-diverse group of  5,970 uninsured individuals served by a large safety-net health system, not up to 
date with screening (30). Mailed invitations were supplemented by telephone calls to promote screening 
completion, and help with scheduling to complete colonoscopy for screening or diagnostic follow up of 
abnormal FIT. At one year, screening was significantly higher for FIT (40.7%) and colonoscopy outreach 
(24.6%) compared to usual care (12.1%), p<0.001 for all comparisons. Among individuals with abnormal FIT, 
82% completed diagnostic colonoscopy. Intervention effects were similar for non-Hispanic whites, non-
Hispanic blacks, and Latinos. Importantly, the interventions were delivered through a safety-net health system 
that included a county-level sliding scale health assistance program that facilitated access to primary and 
specialty care (such as colonoscopy) within the health system – few such comprehensive systems exist in the 
US for underserved populations. Our results with mailed outreach are similar to others offering FOBT (31, 32) or 
colonoscopy (33, 34) outreach, thus suggesting that this approach is consistently effective for promoting 
screening completion compared to usual care.  
However, two main limitations exist. First, as highlighted below, these interventions are under-studied 
among predominantly Latino populations. Second, while effective, none of the studies achieved outcomes 
expected to result in reaching the Health Person 2020 goal of screening 70.5% of the population if 
implemented on a wide-scale. Third, resources required to deliver these interventions can be substantial. For 
example, our intervention included two automated and up to two live phone reminders within 3 weeks, while 
Lasser et al. reported making a median 8.5 calls (associated with a total average phone contact time per 
patient of 107 minutes) during the study period to promote colonoscopy completion (33).  The intensity of 
resources required for these prior interventions have implications for FQHCs seeking to boost screening with 
limited resources. 
 
It is largely unknown whether prior inreach and outreach approaches can be effective among low 
income Latinos, and whether using a combination of strategies will be synergistic for increasing 
screening rates. There are few randomized trials that have focused on either inreach or outreach strategies 
for promoting screening using samples that included substantial (>25%) Latino representation. In fact, little to 
no community-based cancer control intervention research has been conducted on border Latino populations 
outside of Texas. Similar to our prior outreach study, Walsh et al. and Coronado et al., have both reported 
increased screening completion associated with mailed invitation to complete guaiac FOBT compared to usual 
care with and without phone follow up (35). Walsh’s study included an arm with culturally tailored telephone 
follow up (mean 1.7 calls with mean 17 minutes duration), while Corando’s included an arm with promotora-
based telephone follow up (mean duration 10 minutes). Compared to usual care, these interventions improved 
screening by 7 to 29%, with the highest rates associated with telephone follow up – 17% and 29% increases 
for Walsh et al and Coranado et al, respectively. Potter et al. studied an inreach strategy of offering guaiac 
FOBT at time of Flu vaccination at a primary care clinic within a large public hospital (24). Compared to usual 
care with vaccination alone, the Flu-FOBT intervention increased screening completion by 25%; the rate 
compared to usual care individuals not presenting for flu vaccinations was not reported. Jandorf et al.(22) 
studied effects of an inreach patient navigation strategy after physician recommendation for guaiac FOBT 
and/or endoscopic screening (sigmoidoscopy or colonoscopy) in New York City FQHC. Navigation included 
telephone follow and assistance with procedure scheduling if recommended. Navigation resulted in a non-
statistically significant 17% increase in FOBT completion, and a statistically significant 19% increase in 

	  
endoscopic screening completion.  Overall, there appears to be consistent evidence that mailed outreach can 
be effective for promoting screening, including among Latinos. Also, there is limited evidence that inreach 
strategies such as offering FOBT at opportunistic times such as that of  flu vaccination, as well as patient 
navigation can aid in screening completion among Latino populations.  
 
Importantly, none of these interventions (including our own mailed outreach approach) have been 
shown to achieve optimal screening rates among individuals not up to date, and impact of using 
combination approaches (such as inreach and outreach approaches together) has generally not been 
evaluated in FQHC settings. Kaiser Permanente Northern California, a large health maintenance 
organization, has utilized a combination of inreach (including provider reminders), and outreach (including 
mailed FIT invitations with phone follow up) to achieve a screening rate of 79% in 2012 (36), suggesting that 
inreach and outreach may be synergistic. However, utilizing both approaches requires significant resources, 
and it is unknown whether a combination approach would achieve similar results among the underserved 
and/or Latino populations.  
 
Federally Qualified Health Centers (FQHCs) are in a unique and historic position to use existing 
relationships with underserved populations to develop and implement strategies for boosting CRC 
screening. FQHCs have a mission to care for underserved, under- and uninsured populations. It is expected 
that with advent of the Affordable Care Act (ACA), many uninsured patients served by FQHCs will acquire 
health insurance, a prerequisite in most settings to offering CRC screening, and treatment if cancer is found. 
The ACA is also promoting electronic medical record uptake among FQHCs, allowing for better identification 
and tracking of patients and outcomes. Additionally, in 2012, the Department of Health and Human Services 
designated CRC screening as a publically reported Universal Data Set (UDS) measure. Thus, FQHCs have 
new resources and motivation that can enable them to play a central role in identifying individuals not up to 
date, and delivering screening. While recommendations for how to promote screening have been made (37), 
evidence to support efficacy of one strategy vs. another (e.g. inreach vs. outreach), and impact of a 
combination approach, is lacking. Thus, FQHCs have on one hand the urgent need to improve screening rates, 
but on the other hand have significant uncertainty as to which approaches to invest limited resources in for 
promoting screening. New knowledge that elucidates the best approach or combination of approaches for 
promoting screening among underserved populations (particularly Latinos) is thus required.  
 
PILOT RESEARCH 
 
In addition to our previously cited published intervention work in the area of CRC screening, this 
proposal is supported by pilot work that demonstrates the feasibility of the proposed work, elucidate 
key guiding principles for our interventions, and our commitment to the project.  
 
First, we have established an academic-community partnership between UCSD, SDSU, and SYHC. 
Since the fall of 2013, representatives from UCSD Moores Cancer Center (Gupta), SDSU (Talavera, 
Castaneda), and SYHC (Sumek) have worked closely together to forge a partnership around understanding 
barriers to CRC screening at SYHC, identifying key infrastructure required to optimize screening and deliver 
screening interventions, and garnering the support of key leaders at SYHC for the project. This work together 
has facilitated the additional pilot work reported herein.  
 
Second, we have established that FQHCs in our region are keenly interested in understanding the best 
and most practical strategies for screening promotion. In January of 2014, a continuing medical education 
and needs assessment was conducted with 14 directors, administrators and clinic managers from over 10 
Council of Community Clinic member FQHCs to determine interest and readiness for implementation of CRC 
screening programs in San Diego. The meeting included a presentation by Dr. Gupta in which evidence-based 
“best practices” as well as opportunities for future research were identified; this presentation was rated as the 
most important aspect of the meeting in our post-presentation survey. All participants reported that they are 
interested in adopting evidence-based strategies for CRC screening programs and needed technical 
assistance to move forward. Major needs expressed included:  1) additional, more widespread staff and 
provider education, 2) desire to leverage electronic health record (EHR) data to promote screening, and 3) a 
desire to incorporate follow up for CRC screening into existing case management/navigation and referral 
programming, such as those that exist for BC screening and follow-up. 
 

	  
Third, we have identified, through key informant interviews of providers, clinic leadership, experienced 
promotoras, and patients key themes our interventions must address. Ten key informants (non-patients) 
who were knowledgeable about CRC, early detection, SYHC/health care system level issues related to cancer, 
EHR, and the Latino community of focus, participated in 60-minute semi-structured interviews to obtain 
information regarding recommendations for intervention methods and opinions on intervention readiness, 
adoption and implementation issues. Interviews were analyzed using content analysis techniques to describe 
emergent salient themes. Major results from interviews of non-patients included perceptions that 1) tests are 
not offered in a systematic, consistent manner; 2) health literacy among patients with regards to knowledge of 
cancer and specifically CRC is limited, 3) patients have limited knowledge of CRC screening tests, 4) providers 
have limited time to promote and order screening tests, 5) participation in CRC screening needs to be 
“normalized”, 6) navigation-based interventions need to be delivered by an individual perceived to be a peer 
rather than a “jefa” or boss. These observations among non-patients were complemented to some extent by 
observations taken from group interviews of SYHC patients that included questions about needs surrounding 
reducing cancer risk, topics they would like to learn more about regarding CRC, and preferences for how 
information should be presented. SYHC staff recruited 46 Spanish-speaking Latinas age 40-70 waiting for a 
routine health visit; 140 were approached and 92 agreed to participate.  When asked about what things that 
came to mind about reducing cancer risk the top responses included a desire for information on how to 
understand how to reduce risk, request for information on how to have regular screening exams, and concerns 
about fear and death. When asked to share 3 topics they would like to learn more about specifically regarding 
CRC screening, major themes included a desire to obtain more information about screening that is easy to 
understand, wanting to know more about symptoms, risk factors and prevention, information on how to 
manage concerns about embarrassment and shame associated with CRC testing. 
 
Fourth, we have adapted and evolved our prior FIT outreach and patient navigation-based inreach 
strategies for screening promotion suitable for the SYHC clinic setting.  
Outreach strategy: As mentioned above, we previously conducted a randomized comparative effectiveness 
trial that demonstrated the potential for mailed invitation to use and return an enclosed FIT kit, with telephone 
follow up to promote completion, to increase screening rates compared to usual care. In our pilot work, we 
have adapted the mailed FIT strategy for use at FQHCs, and, in the process, also address several potential 
limitations of the prior work. The new proposed strategies that were modified include: 1) mailed invitation to 
complete an enclosed FIT in English and Spanish, 2) low literacy pictorial home-based FIT completion 
instructions, 3) FIT result reporting to patient and primary provider via culturally sensitive means (e.g., by 
phone and in person, not via mail), and 4) telephone assistance with colonoscopy referral and completion for 
individuals with abnormal FIT. To improve on the prior strategy, first, telephone assistance will be done by 
SYHC-based patient navigator, whereas in our prior work telephone assistance was done by a university-
based nurse and medical assistance. Second, we have revised our English and Spanish-language invitation 
letters for use in SYHC’s clinic population, that is largely a low income, unacculturated and low literacy 
population. Third, we will streamline the phone follow up required. The prior intervention utilized two 
automated, and up to two live telephone calls within 3 weeks of mailed invitation to promote screening. 
Because automated phone reminders may not be able to be reliably implemented across FQHCs, we will not 
include this approach in the intervention. Further, an increased, 4-5 week window for delivery of reminder 
phone calls will be allowed to increase the chances of feasible implementation. Fourth, we will develop a 
process for referring individuals with abnormal FIT for diagnostic colonoscopy outside of SYHC based on best 
practices currently utilized by the clinic for breast and cervical cancer screening and follow-up. This step is 
critical, because FQHCs generally have to refer elsewhere for specialty services. Prior to initiation of the 
randomized trial, we will, in additional preparation to research work, conduct a focus group with a random 
sample of 30 patients meeting inclusion/exclusion criteria (men and women, age 50 to 75, not up-to-date with 
screening) recruited from SYHC waiting rooms to review the interventions and study materials to help fine tune 
the outreach strategy. As part of this process, we will procure feedback on additional features (such as 
inclusion of links to internet videos on how to complete the FIT kits, timing of follow phone calls during the 
day/evening) that might improve the effectiveness of the mailed FIT strategy.   
 
Inreach strategy: We have similarly adapted prior inreach strategies tested by our group in the past for the 
specific goal of promoting CRC screening awareness and completion.(38) For example, lessons learned from 
a prior breast cancer navigation study used by the partnership at SYHC show that the average patient load a 
navigator can manage per week is roughly 10 to 12 given the extended time needed for one-on-one patient 
empowerment, motivation, education, and follow-up to link patients with appropriate care. In addition, the 

	  
navigation assistance required to initiate screening is quite often less than that required for follow-up to 
abnormal exams (e.g., which requires diagnostic colonoscopy at an external specialty care site and the 
potential for cancer treatment) due to the individual psychosocial barriers associated with seeking treatment 
(e.g., disbelief in efficacy of treatment, myths about cancer, unawareness of resources available etc). This 
research suggests that culturally appropriate interventions such as in-depth patient navigation can facilitate 
Latinas' successful entry into, and progression through, the cancer care system and improve time from 
screening to diagnosis.  As with our mailed FIT strategy, prior to initiation of the randomized trial, we will 
conduct a focus group with a random sample of 30 individuals meeting inclusion/exclusion criteria for the trial 
to review the interventions and study materials to help fine tune the inreach strategy. 
 
Pilot work summary. Our pilot work demonstrates that the proposed work is feasible, that we are fully 
committed to seeing the work through, and that we have taken significant steps to optimize our proposed 
strategies for the target population. Though our prior work and pilot work has been substantial, we recognize 
several limitations that we will address in the process of the current work. First, while we have developed our 
intervention and intervention materials through community-based participatory research strategies, guided by 
prior work and pilot work, we have not yet pretested the near-final versions among individuals sampled from 
the target population. Second, key informant patient interviews were conducted among women, but have yet to 
be conducted among men. These two limitations will be addressed as part the research approach outlined 
below.  
 
INNOVATION 
The proposed research is innovative for several reasons: 
First, the study will be set at a within one of many FQHCs across the country which share a mission 
for caring for underserved populations and are expected to have an influx of newly insured patients 
who are candidates for screening. SYHC serves over 82,000 unique patients. 84% are Latino, 40% are 
uninsured, 51% have MediCal/Medicaid insurance, and 99% of patients are at or below 200% of the Federal 
Poverty Level. Just as at all FQHCs, many uninsured patients are expected to be newly eligible for insurance 
under the ACA. 
Second, the FQHC selected serves a predominantly low income Latino population – a group that has 
particularly low screening rates and has been understudied with respect to interventions to increase 
screening.  
Third, we will leverage our expertise and infrastructure across three institutions that have a 
commitment to improving health outcomes among underserved populations: SYHC, SDSU, and UCSD. 
Both through and outside of the U54 partnership, these three institutions have a sustained track record of 
funded community based research and publications (See Rationale for Partnership for details). For example, 
currently there are 2 SDSU/SYHC large RCTs at SYHC testing the chronic care model for childhood obesity 
and multiple cardiovascular disease (CVD) risk factors. There are also currently 2 cancer-screening promotora-
based and navigation-basedprojects at SYHC in partnership with SDSU and UCSD. Theses and prior studies 
demonstrate the feasibility of conducting research in this setting. 
Fourth, we propose to test whether inreach and outreach interventions can be effective for 
increasing CRC screening among low-income Latinos and others served by FQHCs. To date, there are 
no published examples that have compared the relative effectiveness of inreach vs. outreach interventions for 
boosting screening, even though these approaches require disparate resources. 
Fifth, we will conduct our study using a randomized controlled trial design that will allow our study 
to not only determine whether inreach and outreach strategies can be effective, but also provide 
valuable data regarding whether there is an interaction associated with using inreach and outreach 
strategies combined. To date, there have not been randomized trials examining whether a combination of 
inreach and outreach might be synergistic for promoting CRC screening – such a combination might be 
required to achieve Healthy People 2020 goals for screening 70.5% of the population. 
 

	  
APPROACH 
 
Conceptual Framework: 
The conceptual 
framework proposed from 
this study stems from the 
Chronic Care model with 
emphasis on re-design of 
the clinical delivery 
system, decision support 
and enhance clinical 
information systems with 
an application to 
proactive promotion of 
clinical preventive 
services (Figure 1)(39).  
 
Overview: We propose a 
randomized trial of a) an inreach strategy, b) FIT outreach, c) the inreach strategy plus FIT outreach, and d) 
usual care for increasing CRC screening among individuals age 50 to 75, not up to date with screening served 
by the SYHC. In Aim 1, we will test the impact of these strategies on screening completion (alone and 
together) among individuals not up to date with screening at SYHC. The primary outcome will be screening 
completion, defined by completion of a CRC screening test (home fecal immunochemical test, home guaiac 
fecal occult blood test, sigmoidoscopy, or colonoscopy) within 6 months of randomization. We will assign 162 
patients (n=648 total) to each group. In Aim 2, we will conduct a process evaluation to examine the 
interventions’ reach, effectiveness, acceptability, feasibility, and sustainability following the RE-AIM framework.  
 
Community-based Research Setting. This study will take place at San Ysidro Health Center, Inc., (SYHC), 
a federally-qualified community health center (CHC), located in the community of San Ysidro in San Diego 
County, California’s most southern county, less than 1 mile from the U.S.-Mexican border entrance to Tijuana, 
Baja California Norte, Mexico. According to the 2010 United States (U.S.) Census, Latinos comprise the 
second largest ethnic group in the U.S and over 37% of Californians and about 29% of San Diegans are 
Latino; yet > 70%  of the South San Diego communities of San Ysidro, Chula Vista, and Imperial Beach, are 
Latino(40). SYHC provides comprehensive health care to 85,731 registered patients annually in South and 
Central San Diego through a service delivery network of 9 primary care clinics, 3 high school clinics, 2 HIV 
centers, 1 adult day health center, 5 WIC centers, 3 mobile clinics, 6 dental clinics, and 6 behavioral health 
service centers. SYHC’s patient profile is predominately Latino (first, second and third generation), with high 
rates of: poverty, uninsured individuals, low education levels, and Spanish speaking households. In 2013, 
SYHC’s patient population profile was highlighted by the following demographics: 76% of SYHC patients were 
Latino (65,440); 90% of patients lived at or below 100% of Federal Poverty Level (76,982); 53% of patients 
were uninsured (45,103); and 32% of patients were ages 0-12 (27,068). 
 
Approach, Aim 1. In Aim 3, we will test the impact of our inreach and mailed FIT outreach strategies on CRC 
screening completion using a rigorous, randomized controlled trial design.  
Prep to research focus groups. As previously mentioned, prior to initiating recruitment for the randomized 
trial, we will conduct focus groups among a random sample of 30 SYHC patients recruited from waiting rooms 
to review our outreach and inreach strategies, and fine tune the interventions. Key points of feedback will 
include clarity of intervention materials, completeness of key educational components, and any need for 
supportive components.  
RCT inclusion/exclusion criteria. We will include individuals age 50 to 75 years, with one or more SYHC 
visits in the last year, at average-risk for CRC but not up-to-date with screening, insured by a MediCal provider, 
Medicare, or private health insurance. We will exclude individuals with personal history of CRC or colorectal 
polyps, as well as the uninsured. Uninsured individuals will be excluded because in absence of health 
insurance, we cannot guarantee that screening (and cancer care if CRC is found) will be financially possible. 
Inclusion and exclusion criteria will be applied through queries of the SYHC EHR.  
Identification of candidate patients and recruitment. Using the SYHC EHR we will enroll and randomize 
648 individuals meeting inclusion/exclusion criteria: 162 to usual care, inreach, mailed FIT outreach, and the 
Providers: 
Promotion 
of 
Preventive 
Service 
Use by 
providers 
and staff 
Long-term 
outcomes: 
Increased regular 
screening & early 
detection  
Preventive Service Use within  
Community Health Centers (FQHC) 
Integrated, Organized, Proactive     
             Patients: 
Behavior: Health care 
use   
Psychosocial and 
Cultural Mediators   
Knowledge 
(understanding of risk)   
Fig. 1 Conceptual 
Model 
Delivery System: 
Structure (Specialty 
care clinic in close 
proximity to FQHC) 
Processes (Use of 
EMR to target 
patients for 
outreach & inreach 
and for follow-up) 
Resources (Case 
management, 
cultural-competent 
staff) 

	  
inreach strategy plus FIT outreach, respectively (see sample size and power calculations below). A waiver of 
documentation of informed consent will be obtained for randomization and intervention delivery based on two 
primary factors: 1) goal of increasing screening for as many individuals as possible, and 2) scientific advantage 
of observing as close to “real world” impact of the planned strategies on asample of patients. We reviewed with 
our Institutional Review Board a potential strategy for complete waiver of informed consent, but were advised 
that maximizing patient autonomy and awareness of potential loss of confidentiality associated with research 
data collection merited at minimum a one-page informational research “fact sheet” that would provide patients 
with information about the research project. In the letter, patients will be the option to specifically note a desire 
not to participate in the intervention or subsequent data collection. Recruitment will continue until a sample size 
of 162 individuals per group who do not opt out of the research is achieved. In our primary, intent to screen 
analysis, we will analyze all randomized individuals who do not opt out of the research.  
The EHR will be queried 4 times over a 1 year period. At time of each query 1/4 of the target sample will be 
identified and randomized, and have the assigned interventions initiated. Each group will be followed for 12 
months for the primary outcome: completion of any CRC screening test (guaiac fecal occult blood test, FIT, 
sigmoidoscopy, or colonoscopy), measured by evidence of screening documented within the EHR. Thus, the 
total recruitment period will last 12 months, and the duration through completion of 6 month follow up of all 
patients will be 24 months. Measurements will include demographic information (race, ethnicity, sex, and age), 
number and location of health center visits, primary provider, and comorbid medical conditions. In secondary 
analyses, we will determine whether screening rates vary across these characteristics, and also assess 
whether for significant interactions between characteristics and intervention effects.  
Analytic approach and sample size, Aim 1. We estimated the sample size for 5 comparisons (usual care 
vs. inreach, usual care vs. outreach, usual care vs. inreach + outreach, inreach + outreach vs. outreach alone, 
and inreach + outreach vs. inreach alone), assuming alpha = 0.01 across all groups and power >0.8. For these 
assessments, we assumed the following rates of screening on follow up among individuals not up to date at 
baseline: 10% for usual care, 25% for inreach, 25% for outreach, 45% for inreach + outreach combined. The 
10% rate for usual care and 25% estimate for outreach were conservative assumptions based on our 
previously cited work (30). The 25% rate for inreach was a conservative estimate based on observations that 
inreach interventions such as patient navigation have boosted screening completion (among patients referred 
for colonoscopy) by 41 to 78%. Finally, the 45% rate for both interventions combined was considered the 
minimal clinically significant difference that would justify implementing two different interventions for increasing 
screening. Under these assumptions, we computed need for a sample size of n=648 patients (n=162 for each 
group) to have sufficient power for all primary comparisons of interest.  
The primary outcome is completion of any CRC screening test (guaiac fecal occult blood test, FIT, 
sigmoidoscopy, or colonoscopy) within 12 months of randomization. The analytic approach taken will 
depend on whether or not an interaction exists between the outreach and inreach strategies on screening 
completion. If no interaction is present, screening rates for inreach vs. usual care and outreach vs. usual care 
will be compared using a Chi-square test of proportions, requiring p<0.01 for statistical significance. If 
interaction is noted, we will compare screening rates with a Chi-square test of proportions for inreach without 
outreach vs. usual care, as well as inreach with outreach vs. usual care separately, using a p<0.025 to indicate 
statistical significance. In both cases (interaction or no interaction), secondary comparisons will include inreach 
plus outreach vs. usual care, as well as inreach plus outreach vs. either strategy alone. We will conduct 
additional analyses treating screening completion as the dependent variable, and examine the relationship of 
group assignment, demographic characteristics, primary provider, and clinic visit frequency to this outcome. 
Factors associated with screening completion on univariate analyses will be considered as part of a logistic 
regression model examining factors independently associated with screening completion; in the case of 
interaction by group assignment a term for interaction will be included in our models. Additionally, interactions 
between other factors (e.g. gender, age, language preference, income, inreach strategy and frequency of clinic 
visits) will be considered.  
 
Approach, Aim 2 Process Evaluation. Following the RE-AIM framework(41-43), a quasi-experimental 
process evaluation of intervention programs is proposed as part of the research protocol using validated 
measures developed in previous studies(44). This process evaluation is designed to examine the intervention’s 
acceptability, feasibility, and sustainability(45-47). Process measures include: intervention fidelity, recruitment 
and retention issues, dosage delivered and received, participant satisfaction, and navigator perceptions on 
areas for improvement in each one-on-one session. Dr. Castañeda, Ms. Sumek, and Ms. Espinoza will lead 
trainings to ensure intervention fidelity and standardized intervention delivery and dosage.  

	  
 
Team Management Plan. The study team includes Samir Gupta, Greg Talavera, Sheila Castañeda, Kristi 
Wells, Lin Liu, and Caryn Sumek. All have extensive experience with conducted research and promoting health 
among underserved populations. The research team currently has 2 NIH- funded and 1 ACS funded RCT 
studies at SYHC focusing on chronic disease, and cancer navigation (see Biosketches). Successful 
recruitment, intervention, and measurement methods and from these studies will be used in the proposed 
study for formal protocol development. The team will work collaboratively to set goals, timelines, and achieve 
study objectives. Drs. Talavera, Castañeda, and Wells will lead the final prep to research work required for 
finalizing study interventions. Dr. Gupta will lead planning and evaluation of Aim 1. Dr. Liu will serve as the lead 
biostatistician for analyses. Dr. Castañeda will lead the Aim 2 process evaluation. Ms. Sumek will play a critical 
role in leading the execution of activities under Aims 1 and 2 at the SYHC setting, including day-to-day 
management of study activities and interventions. All investigators will participate in analysis, interpretation, 
and publication of results.  
 
Threats to Validity.  Contamination due to the potential exchange of information between the intervention 
groups is a recognized threat to the integrity of the proposed study design due to nature of the study setting. 
Evidence from our pilot work suggests this has not been an issue to date. The SYHC has over 90,000 
registered patients that it serves in the target area. As recruitment proceeds, eligibility screening will include 
examining if family members are already participating in the proposed study. The staff selected for the 
interventions have comparable experience working within the community of interest, knowledge and training of 
selected topics to be covered during the navigation sessions, are bilingual (Spanish/English) and bicultural 
(Mexican-heritage). Findings would have external validity for other community health center settings, but 
limited validity to organizations that target middle and upper class populations.   
 
Data Management and Quality Control.  Data management will be an on-going activity designed to ensure 
the highest quality data possible. Activities include data-coding, computer data entry, data quality control and 
tracking, data confidentiality and development of data files for statistical analysis. Prior to data entry, forms will 
be examined for completeness and accuracy. A tracking system will be developed to ensure all forms have 
been administered to participants. Completed forms will be entered into the database using a double data entry 
verification system. All identified errors will be resolved using the original hard data. All corrected fields will be 
noted for a detailed audit trail. Forms will be kept in locked files at the SYHC. Subjects will be assigned study 
ID numbers to be linked with SYHC medical record numbers on data management and data analysis files. No 
identifiable information will be used in reports. Data entered and stored will be periodically archived on the 
secure SYHC server. Data entry and analysis will be performed on Pentium-based computers. Analyses will be 
carried out using SPSS and SAS by the study statistician (Dr. Lin Liu at UCSD) who will receive a deidentified 
dataset from SYHC.  
 
Timeline  
Timeline (anticipated start date September 1, 2015) 
 
Year 1 
Year 2 
Year 3 
TASKS 
Q 
1 
Q 
2 
Q 
3 
Q 
4 
Q 
1 
Q 
2 
Q 
3 
Q 
4 
Q 
1 
Q 
2 
Q 
3 
Q
4 
Weekly academic-community partnership team meetings 
 
 
 
 
 
 
 
 
 
 
 
 
Prep to research finalization of interventions 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Compare CRC screening rates associated with use of a) the inreach strategy, b) the mailed FIT outreach strategy (FIT outreach), c) 
inreach + FIT outreach, and d) usual care among n=648 individuals randomized across these groups. 
a. Random Assignment and Intervention (1/4 sample size per Q, Q1-4) 
b. Completion of 12-month follow up for outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
c. RCT Analyses 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Process evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
a. Process evaluation data collection 
 
 
 
 
 
 
 
 
 
 
 
 
b. Process evaluation data analyses 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination of results through community and academic conferences and publications, 
Preparation of subsequent grant applications 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Impact and Next Steps. Several outcomes are anticipated as a result of this work. First, we will optimize two 
interventions for increasing CRC screening among underserved populations, particularly low income Latinos. 
We will then conduct a rigorous randomized trial of these interventions, including an assessment of whether 
inreach and outreach interventions are complimentary (and perhaps even synergistic) for boosting CRC 

	  
screening among underserved populations. Locally, if successful, this program would be adopted into ongoing 
standard of care for patient preventive service utilization at SYHC. Integrated implementation is highly likely at 
SYHC because the program fits with the health center’s strategic organizational restructuring to align with 
health care reform and the new “Patient-Centered Medical Home” initiative, which promotes patient-centered 
integrative care, patient empowerment, care coordination, and a deeper focus on meeting clinical preventive 
service guidelines for all patients. Regionally and nationally, we will disseminate findings, lessons learned, and 
best practices to key community groups, research experts, and policy-makers facilitated through meetings of 
our local Council of Community Clinics, the National Association of Community Health Centers, the California 
Colorectal Cancer Coaltion, and national and international scientific organizations. Extramural grant 
applications to study impact of implementing our findings in usual practice will be proposed (particularly 
considering the large number of FQHCs based in San Diego County), along with grant applications designed to 
test novel and/or improved interventions for boosting screening informed by the results of our work. To inform 
public health policy, we also expect data from this and future work to be used for cost-effectiveness analyses 
of our intervention strategies for boosting screening, as well as to support funds for implementation of 
population-based screening programs to promote CRC screening. 

	  
RATIONALE FOR SDSU, UCSD, and SYHC COLLABORATION  
The collaboration proposed for this proposal meets many of the ideal criteria specified in the U54 RFA.  
First, we propose a hypothesis-driven cancer prevention outreach project focused on reducing 
disparities in CRC screening among low-income Latinos. Our proposal includes randomized trial that will 
allow for highly interpretable results, whether or not our hypotheses are correct. Setting the study at a FQHC 
ensures that the research is focused on an underserved population, but also increases the chances that 
findings might be implementable in other, similar settings across the nation. 
Second, each of the partners (UCSD, SDSU, and SYHC) brings unique expertise and opportunities to 
the partnership. UCSD/Moores Cancer Center is represented by Dr. Gupta, a gastroenterologist with 
significant clinical expertise in CRC screening, as well as research expertise and experience in the use of 
randomized controlled trials to test intervention strategies for increasing screening among underserved 
populations. He is a member of the Reducing Cancer Disparities program at the Moores Cancer Center, and 
also plays a role in promoting awareness of screening disparities and implementation of strategies to address 
disparities at a national level, as exemplified by invitations to speak at scientific forums and publication of his 
work in high impact journals.  
SDSU is represented by Drs. Talavera, Castañeda, and Wells, who are members of the Institute for 
Behavioral and Community Health (IBACH) and the Reducing Cancer Disparities program at the Moores 
Cancer Center. IBACH’s mission since 1987 has been to build the evidence-base regarding social, cultural, 
and built environmental factors associated with chronic disease risk and design interventions that ameliorate 
these factors. Dr. Talavera is a Professor at SDSU, Graduate School of Public Health, and Co-Director for 
IBACH. Dr. Talavera is a bilingual bicultural physician scientist who has been working in the field of Latino 
cancer disparities for over 25 years. Since 1987, Dr. Talavera has collaborated with SYHC on ~15 health 
promotion/research projects that have involved clinic patients directly or the community they serve, 11 of which 
included subcontracts to SYHC and 4 of which were randomized clinical trials.  His grants and contracts have 
totaled over $20 million in costs. Dr. Castañeda is a Research Assistant Professor at IBACH, and the Graduate 
School of Public Health at SDSU. She is a community psychologist who has specialized training in community 
empowerment, capacity building, community-based participatory research, mixed-methods, Latino cancer 
disparities, partnership development, and evaluation. Dr. Castañeda has held many key community-based 
leadership positions, such as for the NCI-funded Redes en Accion Outreach Core and Dissemination efforts.  
She has over 14 years of community-based cancer research experience and over 23 publications reflecting 
this experience. Dr. Wells is an Assistant Professor in the Department of Psychology at SDSU, and has 
graduate training in Clinical Psychology and Public Health, followed by post-doctoral training in behavioral 
oncology. Since 1997, she has been engaged in public health research focused on improving the quality of 
cancer care delivered to underserved populations, with a specific specialty in patient navigation and 
community-based research, reflected in over 50 publications in this area.   
SYHC and its Center for Health Promotion and Research (CHPR) are represented by Ms. Sumek, the 
Community PI for this proposal. Ms. Sumek has training and experience in community-based program 
development, strategic planning, grant writing, health promotion, and community-based intervention 
implementation. Ms. Sumek manages several other grants funded by SDSU. Ms. Sumek will be responsible 
for overseeing the project planning and implementation, the research staff and project supervisor, and 
working with the academic PIs to ensure intervention fidelity and that the goals are met. CHPR currently 
houses 13 grant-funded projects, 2 clinic-wide initiatives, and ~40 staff. CHPR serves SYHC patients and the 
surrounding community by researching health issues that have a direct impact on disparities, and providing 
culturally- and linguistically-appropriate health promotion interventions. SYHC has organizational capacities 
necessary for developing, adapting, and implementing evidence-based programs, such as financial means, 
personnel and management structure.  
Third, the partnership will provide valuable training opportunities; for learning about disparities and 
participating in research that resolves disparities, and for training under-represented minorities to 
become cancer research scientists.  Drs. Gupta, Castañeda, and Wells have had significant success in 
research in the area of cancer disparities, yet none has served as PI of a NIH/NCI R01 grant; completing the 
proposed study will markedly increase the chances that both will be in a position to compete as a team for R01 
level grants. Additionally, the project itself will offer numerous opportunities for underrepresented minority 
students from various levels (undergraduate, graduate, and post doctoral) to participate in research activities 
ranging from intervention delivery and data collection, to secondary analyses of study data to explore novel 
hypotheses.  Thus, our partnership will work with senior investigators among the U54 partnership training core 
to utilize the results from this study to help advance our research careers 

	  
  
 
REFERENCES 
 
1. 
Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA: a cancer journal for clinicians. 
2014;64(1):9-29. 
2. 
Kahi CJ, Imperiale TF, Juliar BE, Rex DK. Effect of screening colonoscopy on colorectal cancer 
incidence and mortality. Clinical gastroenterology and hepatology : the official clinical practice journal of 
the American Gastroenterological Association. 2009;7(7):770-5; quiz 11. 
3. 
Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer 
after colonoscopy: a population-based, case-control study. Annals of internal medicine. 2011;154(1):22-
30. 
4. 
Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, et al. Colorectal-cancer 
incidence and mortality with screening flexible sigmoidoscopy. The New England journal of medicine. 
2012;366(25):2345-57. 
5. 
Shaukat A, Mongin SJ, Geisser MS, Lederle FA, Bond JH, Mandel JS, et al. Long-term mortality after 
screening for colorectal cancer. The New England journal of medicine. 2013;369(12):1106-14. 
6. 
Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, et al. Long-term colorectal-cancer 
incidence and mortality after lower endoscopy. The New England journal of medicine. 
2013;369(12):1095-105. 
7. 
Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, et al. Once-only flexible 
sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. 
Lancet. 2010;375(9726):1624-33. 
8. 
Brown ML, Klabunde CN, Cronin KA, White MC, Richardson LC, McNeel TS. Challenges in meeting 
healthy people 2020 objectives for cancer-related preventive services, national health interview survey, 
2008 and 2010. Preventing chronic disease. 2014;11:E29. 
9. 
Gupta S, Sussman D, A. C, Doubeni C, Anderson D, Day L, et al. Challenges and Possible Solutions to 
Colorectal Cancer Screening for the Underserved. J Natl Cancer Inst. 2014;106(4). 
10. 
Centers for Disease Control and Prevention. Cancer screening—United States, 2010. MMWR Morb 
Mortal Wkly Rep. 2012. 
11. 
Klabunde CN, Cronin KA, Breen N, Waldron WR, Ambs AH, Nadel MR. Trends in colorectal cancer test 
use among vulnerable populations in the United States. Cancer epidemiology, biomarkers & prevention 
: a publication of the American Association for Cancer Research, cosponsored by the American Society 
of Preventive Oncology. 2011;20(8):1611-21. 
12. 
Siegel R, Naishadham D, Jemal A. Cancer statistics for Hispanics/Latinos, 2012. CA: a cancer journal 
for clinicians. 2012;62(5):283-98. 
13. 
Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, et al. Association of insurance with 
cancer care utilization and outcomes. CA: a cancer journal for clinicians. 2008;58(1):9-31. 
14. 
US Census 2010 Health insurance coverage status and type of coverage by selected characteristics. . 
15. 
Colorectal cancer stage distribution (SEER Summary Stage 2000) for non-Hispanic whites vs. 
Hispanics, all ages, both sexes, 2000-2010. . 
16. 
American Cancer Society. Colorectal Cancer Facts & Figures 
2008-2010. Atlanta, GA: 2008. 
17. 
Fernandez ME, Wippold R, Torres-Vigil I, Byrd T, Freeberg D, Bains Y, et al. Colorectal cancer 
screening among Latinos from U.S. cities along the Texas-Mexico border. Cancer causes & control : 
CCC. 2008;19(2):195-206. 
18. 
 Institute of Medicine. Speaking of Health: Assessing Health Communication Strategies for Diverse 
Populations. Washington, DC: The National Academics Press, 2002. 
19. 
Marcus AC, Mason M, Wolfe P, Rimer BK, Lipkus I, Strecher V, et al. The efficacy of tailored print 
materials in promoting colorectal cancer screening: results from a randomized trial involving callers to 
the National Cancer Institute's Cancer Information Service. Journal of health communication. 2005;10 
Suppl 1:83-104. 
20. 
Levin TR, Jamieson L, Burley DA, Reyes J, Oehrli M, Caldwell C. Organized colorectal cancer 
screening in integrated health care systems. Epidemiologic reviews. 2011;33(1):101-10. 
21. 
Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, et al. Effectiveness of 
interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic 

	  
reviews for the guide to community preventive services. American journal of preventive medicine. 
2012;43(1):97-118. 
22. 
Jandorf L, Gutierrez Y, Lopez J, Christie J, Itzkowitz SH. Use of a patient navigator to increase 
colorectal cancer screening in an urban neighborhood health clinic. Journal of urban health : bulletin of 
the New York Academy of Medicine. 2005;82(2):216-24. 
23. 
Christie J, Itzkowitz S, Lihau-Nkanza I, Castillo A, Redd W, Jandorf L. A randomized controlled trial 
using patient navigation to increase colonoscopy screening among low-income minorities. Journal of 
the National Medical Association. 2008;100(3):278-84. 
24. 
Potter MB, Phengrasamy L, Hudes ES, McPhee SJ, Walsh JM. Offering annual fecal occult blood tests 
at annual flu shot clinics increases colorectal cancer screening rates. Annals of family medicine. 
2009;7(1):17-23. 
25. 
Walsh JM, Gildengorin G, Green LW, Jenkins J, Potter MB. The FLU-FOBT Program in community 
clinics: durable benefits of a randomized controlled trial. Health education research. 2012;27(5):886-94. 
26. 
Potter MB, Somkin CP, Ackerson LM, Gomez V, Dao T, Horberg MA, et al. The FLU-FIT program: an 
effective colorectal cancer screening program for high volume flu shot clinics. The American journal of 
managed care. 2011;17(8):577-83. 
27. 
Potter MB, Walsh JM, Yu TM, Gildengorin G, Green LW, McPhee SJ. The effectiveness of the FLU-
FOBT program in primary care a randomized trial. American journal of preventive medicine. 
2011;41(1):9-16. 
28. 
Castaneda SF, Xiong Y, Gallo LC, Yepes-Rios M, Ji M, Talavera AC, et al. Colorectal cancer 
educational intervention targeting latino patients attending a community health center. Journal of 
primary care & community health. 2012;3(3):164-9. 
29. 
Potter MB, Ackerson LM, Gomez V, Walsh JM, Green LW, Levin TR, et al. Effectiveness and reach of 
the FLU-FIT program in an integrated health care system: a multisite randomized trial. American journal 
of public health. 2013;103(6):1128-33. 
30. 
Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, et al. Comparative Effectiveness of 
Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal 
Cancer Screening Among the Underserved: A Randomized Clinical Trial. JAMA internal medicine. 
2013;173(18):1725-32. 
31. 
Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve 
colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. 
Annals of family medicine. 2012;10(5):412-7. 
32. 
Myers RE, Sifri R, Hyslop T, Rosenthal M, Vernon SW, Cocroft J, et al. A randomized controlled trial of 
the impact of targeted and tailored interventions on colorectal cancer screening. Cancer. 
2007;110(9):2083-91. 
33. 
Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, et al. Colorectal cancer 
screening among ethnically diverse, low-income patients: a randomized controlled trial. Archives of 
internal medicine. 2011;171(10):906-12. 
34. 
Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, et al. A culturally tailored 
navigator program for colorectal cancer screening in a community health center: a randomized, 
controlled trial. Journal of general internal medicine. 2009;24(2):211-7. 
35. 
Coronado GD, Golovaty I, Longton G, Levy L, Jimenez R. Effectiveness of a clinic-based colorectal 
cancer screening promotion program for underserved Hispanics. Cancer. 2011;117(8):1745-54. 
36. 
Lee JK, Levin TR, Corley DA. The road ahead: what if gastroenterologists were accountable for 
preventing colorectal cancer? Clinical gastroenterology and hepatology : the official clinical practice 
journal of the American Gastroenterological Association. 2013;11(3):204-7. 
37. 
Sarfaty M, Doroshenk M, Hotz J, Brooks D, Hayashi S, Davis TC, et al. Strategies for expanding 
colorectal cancer screening at community health centers. CA: a cancer journal for clinicians. 
2013;63(4):221-31. 
38. 
Ramirez AG, Perez-Stable EJ, Talavera GA, Penedo FJ, Carrillo JE, Fernandez ME, et al. Time to 
definitive diagnosis of breast cancer in Latina and non-Hispanic white women: the six cities study. 
SpringerPlus. 2013;2(1):84. 
39. 
Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, et al. The effectiveness of 
disease and case management for people with diabetes. A systematic review. American journal of 
preventive medicine. 2002;22(4 Suppl):15-38. 

	  
40. 
U.S. Census Bureau. The Hispanic Population: 2010, 2010 Census Briefs 2013 [cited 2013 November 
20]. Available from: http://www.census.gov/prod/cen2010/briefs/c2010br-04.pdf. 
41. 
Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: 
what can it tell us about approaches to chronic illness management? Patient education and counseling. 
2001;44(2):119-27. 
42. 
Glasgow RE, Nelson CC, Strycker LA, King DK. Using RE-AIM metrics to evaluate diabetes self-
management support interventions. American journal of preventive medicine. 2006;30(1):67-73. 
43. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: 
the RE-AIM framework. American journal of public health. 1999;89(9):1322-7. 
44. 
Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo LC. Peer-led diabetes education 
programs in high-risk Mexican Americans improve glycemic control compared with standard 
approaches: a Project Dulce promotora randomized trial. Diabetes care. 2011;34(9):1926-31. 
45. 
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating 
complex interventions: the new Medical Research Council guidance. BMJ (Clinical research ed). 
2008;337:a1655. 
46. 
Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health 
promotion program implementation: a how-to guide. Health promotion practice. 2005;6(2):134-47. 
47. 
Steckler A, Linnan L. Process Evaluation for Public Health Interventions and Research. San Francisco, 
CA: Jossey-Bass; 2002.