A culturally and linguistically salient pilot intervention to promote colorectal cancer screening among Latinos receiving care in a Federally Qualified Health Center

Abstract

Despite established benefits, colorectal cancer (CRC) screening is underutilized among Latinos/Hispanics. We conducted a pilot 2-arm randomized controlled trial evaluating efficacy of two intervention conditions on CRC screening uptake among Latinos receiving care in community clinics. Participants (N = 76) were aged 50–75, most were foreign-born, preferred to receive their health information in Spanish, and not up-to-date with CRC screening. Participants were randomized to either a culturally linguistically targeted Spanish-language fotonovela booklet and DVD intervention plus fecal immunochemical test [FIT] (the LCARES, Latinos Colorectal Cancer Awareness, Research, Education and Screening intervention group); or a non-targeted intervention that included a standard Spanish-language booklet plus FIT (comparison group). Measures assessed socio-demographic variables, health literacy, CRC screening behavior, awareness and beliefs. Overall, FIT uptake was 87%, exceeding the National Colorectal Cancer Roundtable’s goal of 80% by 2018. The LCARES intervention group had higher FIT uptake than did the comparison group (90% versus 83%), albeit not statistically significant (P = 0.379). The LCARES intervention group was associated with greater increases in CRC awareness (P = 0.046) and susceptibility (P = 0.013). In contrast, cancer worry increased more in the comparison group (P = 0.045). Providing educational materials and a FIT kit to Spanish-language preferring Latinos receiving care in community clinics is a promising strategy to bolster CRC screening uptake to meet national targets.

Introduction

Cancer accounts for 21% of deaths overall among the US Hispanics/Latinos, the fastest growing racial/ethnic minority group in the United States [1]. Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in this population [1, 2]. Despite well-documented benefits [3, 4], CRC screening remains markedly underutilized among medically underserved Latinos [2, 5]. Addressing low CRC screening rates will aid in reducing the cancer burden among Latinos and advance efforts to achieve the 80% by 2018 screening goal to prevent CRC deaths [6, 7].

The American Cancer Society and US Preventive Services Task Force recommend adults at average risk for CRC to begin asymptomatic screening at age 50 [8]. Recommended CRC screening modalities for average risk individuals include: colonoscopy every 10 years, flexible sigmoidoscopy every 5 years, double-contrast barium enema every 5 years, computed tomographic colonography every 5 years, multi-targeted stool DNA test every 3 years, annual fecal occult blood test (FOBT), or annual fecal immunochemical test (FIT) [5, 9–11].

Although colonoscopy is the most thorough [3, 4], FOBT and FIT have strong evidence of clinical effectiveness established in randomized controlled trials (RCTs) [12, 13], are highly accessible, convenient and easy-to-perform [3, 4]. Whereas previous guaiac-based or other forms of FOBT required patients to collect stool samples on three different days (and low temperature storage), the FIT detects hemoglobin in stool samples and has higher sensitivity and specificity [14]. Often requiring only one sample and with no dietary restrictions, the sampling procedure is patient-friendly compared with guaiac-based or other forms of FOBT [15–17]. Recent studies suggest the public prefers FIT over colonoscopy [18, 19] and FIT implementation is greater in clinic populations than in colonoscopy [20]. These data lend strong support for FIT as an initial screening method for an average risk individual [3, 4] reserving colonoscopy for those with an abnormal finding.

Factors that account for low CRC screening include low awareness of its importance, limited access to care or lack of provider recommendation [5, 21]. Furthermore, cancer information that is not language-specific or that is steeped in complex terminology serves little purpose. Thus, an important feature in promoting screening behaviors is the provision of culturally, and linguistically salient information that is mindful of audiences at-risk of low-literacy (e.g. those who may have difficulty in obtaining, processing and understanding health information) [22–24]. CRC education paired with an accessible, easy-to-use screening tool, such as FIT, and distributed within neighborhood community-based health clinics [3, 4], may have a high potential to greatly impact cancer-related disparities for Latinos.

This study evaluates the impact of a Spanish-language, low-literacy culturally targeted intervention (fotonovela+DVD+FIT) (denoted as Latinos Colorectal Cancer Awareness, Research, Education and Screening [LCARES] condition) compared with a standard Spanish-language brochure developed by the Centers for Disease Control and Prevention (CDC)+FIT (denoted as comparison condition).

The current pilot study investigated intervention group differences in FIT kit return and changes in CRC awareness and in health beliefs by intervention group from baseline to 3-month post-intervention follow-up. The preventive health model (PHM), previously applied to predict behavior and intention of CRC screening [25, 26], provided theoretical grounding for our study. The overarching hypothesis was that the LCARES intervention (fotonovela+DVD+FIT) would be associated with greater FIT uptake and greater post-intervention changes in awareness and health beliefs compared with comparison condition (CDC brochure+FIT).

Methods

Design

This randomized pilot intervention study was conceptualized, designed and implemented based on community-based participatory research principles within the context of the Tampa Bay Community Cancer Network (TBCCN). Established in 2005, TBCCN, a community network program center funded by the National Cancer Institute addresses critical access in cancer prevention and control among medically underserved, low-literacy and low-income populations leveraging longstanding community-academic partnerships [27]. This study concept originated from an identified need to address barriers to CRC by TBCCN partner members, the noted unequal burden among Latinos, and a dearth of materials or studies focused on Spanish language-preferring Latinos. It was fueled by the team’s prior work in carrying out an English-language Colorectal Cancer Awareness, Research, Education and Screening RCT that produced FIT uptake rates of more than 80% in Federally Qualified Health Centers (FQHCs) and other community clinics [28]. The University of South Florida Institutional Review Board approved the study.

Setting

The study was conducted at two clinics in a Southwest Florida FQHC network that annually serves a large number (n ∼ 5000) of medically underserved patients (ages 50–75), a majority of whom are of Latino/Hispanic origin and from diverse nationalities, and include farmworker populations. Eligible participants were those (i) receiving care at the participating clinics, (ii) aged 50–75 years, (iii) who self-identified as Hispanic/Latino, (iv) able to read, speak, and understand Spanish, (v) preferred to receive health information in Spanish, (vi) currently not up-to-date per CRC screening guidelines (never screened or previously screened but now overdue) and (vii) at average risk for CRC (no symptoms of CRC, personal diagnosis of CRC or bowel diseases, and without family history of CRC). Eligible individuals provided written informed consent before baseline data collection and randomization.

Intervention

The LCARES intervention featured a Spanish language, low-literacy, culturally targeted fotonovela booklet and DVD titled, ‘Un examen sencillo para un colon saludable’—a simple test for a healthy colon—informed by the constructs of the PHM (e.g. salience and coherence, cancer worry and self-efficacy) plus FIT kit. The fotonovela included storylines depicting characters that modeled the test-specific behavior of FIT screening. The fotonovela/DVD content, linguistics storyline, photos and graphics were informed by an extensive formative phase which included a series of focus groups and iterative processes to produce the intervention [29]. Individuals in the comparison condition received a standard Spanish-language booklet developed by the CDC, ‘Las preubas de detección de cáncer colorrectal salvan vidas,’ plus a FIT kit.

Procedures

After clinic registration, potential participants were greeted by trained bilingual study coordinators who introduced the study and assessed the participant’s eligibility. For those individuals found to be eligible, the study coordinator further described the study and obtained written informed consent. Average patient wait times range from 35 to 45 minutes in the clinics—sufficient time to implement the recruitment, enrollment and educational intervention before the patient’s encounter with practitioner.

Study assessments consisted of validated, translated (Spanish) measures (see ‘Measures’ section) administered by study coordinators at baseline (in-person) and 3-month follow-up (phone interview). All questions were read aloud for all participants to minimize literacy issues. After completion of baseline assessments, participants were randomized (1:1) to receive either the LCARES or comparison condition. Participants in the LCARES condition viewed the DVD in clinic and received a copy of the DVD and fotonovela booklet to take home. Participants in the comparison group were provided the CDC brochure to review at their convenience in clinic and at home. In addition, all enrolled participants received a FIT kit, written and verbal FIT kit collection instructions, and a self-addressed, stamped envelope to mail the FIT kit for processing. Reminder letters were mailed to participants who had not returned the FIT kit 2 weeks after study entry. Returned FIT kits were processed by the cancer center’s clinical laboratory. Participants were called with FIT kit results and were also mailed a physician-signed results letter. Participants with abnormal FIT results were assisted to access a screening colonoscopy. Participants received a $15 gift card at baseline and $15 gift card at 3-month follow-up, as compensation for their time spent completing study-related interviews.

Measures

Screening uptake

Screening uptake was evaluated by return of a completed FIT kit to the study team at the cancer center using pre-stamped and self-addressed mailers. This provided an objective verification of screening completion. The primary outcome was return of a completed FIT kit within 90 days of intervention delivery (coded as yes or no). Time to FIT kit return was a secondary outcome.

Awareness of colorectal cancer and screening tests

Awareness of CRC and CRC screening tests were assessed (baseline and at 3-month post-intervention) using three questions adapted from NCI’s Health Information National Trends Survey and three items derived from the literature [10, 28, 30] for a total of six items. One item comprised several options for a possible score of 4; another two items had a possible score of 2, the remaining items were coded 0 for no and 1 for yes. A total awareness score was calculated by summing the points earned for all awareness items; total score ranges from 0 to 11.

PHM variables

Seven constructs from the PHM most pertinent to CRC screening and consistent with previous CRC screening studies with multi-ethnic populations were assessed in this study and were selected for their brevity and relevance [25, 26, 31, 32]. These constructs were assessed at baseline and at follow-up (3 months). Salience and coherence, or the participant’s perception that performing a health behavior is consistent with his/her beliefs about how to protect and maintain health, was measured with four items. Perceived susceptibility, or subjective personal risk for developing CRC or polyps, was measured with three items. Cancer worry, or concern about the negative consequences of completing the screening behavior, was measured with two items. Response efficacy, or belief that adopting a behavior will be effective in reducing disease threat, was measured with two items. Social influence, or beliefs about and desire to comply with key references’ attitudes toward CRC screening, was measured by four items, referencing the influence of family members and doctor/health professionals. Religious beliefs, a five-item scale assessing how religious beliefs might influence medical-decision making such as CRC screening has been used in our prior studies with adequate reliability [10, 28]. Self-efficacy for screening using FIT, or attitudes and confidence toward completing FIT, was measured with six items.

Single item literacy screener (SILS)

Health literacy characteristics were measured at baseline using two single item questions which have been found to be meaningful and acceptable in prior research endeavors [33]. Questions assessed confidence in completing health forms by oneself (with responses ranging from 0 for ‘very confident’ to 3 for ‘almost always ask for help’) and frequency of difficulty with reading written materials (with responses ranging from 0 for ‘never’ to 2 for ‘always’).

Socio-demographic characteristics

Variables including age, gender, race/ethnicity, foreign-born status and country of origin, years lived in the United States (if foreign-born), marital status, education, insurance status, employment status and income were assessed at baseline using items from the literature.

Statistical analysis

Socio-demographic characteristics and health literacy items were summarized using descriptive statistics. Preliminary analyses were performed to assess any potential group differences (despite randomization). Those variables with P < 0.10 were incorporated into primary logistic regression analyses assessing the effect of the LCARES intervention on FIT kit return. Changes in health-related variables were analyzed using mixed-design ANOVA for those who completed the post-intervention session (n = 59) with α = 0.05. All analyses were conducted using SAS 9.4 [34].

Results

Recruitment and enrollment

A total of 234 patients were evaluated and 81 were determined to be eligible (Fig. 1). The primary reasons for ineligibility (n = 153) included self-report of being up-to-date with CRC screening (73%) and language preference other than Spanish (11%). The total number of eligible individuals enrolled was 76 (five declined to participate). Of the 76 enrolled, 40 were randomized to the LCARES intervention and 36 were randomized to the comparison condition. Accrual required 7 months. Fifty-nine participants completed the 3-month follow-up interview (32 in LCARES condition and 27 in the comparison condition). A total of 13 participants were considered lost to follow-up.

Fig. 1.

LCARES consort flow diagram.

Participant characteristics

Table I summarizes socio-demographic characteristics and health literacy for each condition at enrollment. All participants were Latino/Hispanic. The average age of participants was 57.2 years (SD = 6.0). The majority of participants was female (67%) and 67% reported race as ‘other’. Most participants were married or living with a partner (70%), employed (53%) and 44% had an annual income less than $10 000. In terms of reported years of education, 43% reported their highest level of schooling was elementary (6th grade or less). The majority of participants did not have health insurance (75%), and 93% were born outside the United States (immigrant). For the two health literacy items, 75% reported being very confident in completing health forms and 47% reported having difficulty reading written materials concerning health. Despite randomization, the LCARES group had a higher percentage identifying as ‘other’ race and an annual income less than $10 000.

Table I.

Descriptive statistics for socio-demographics and health literacy at baseline

Variable	Level	Comparison (n = 36) M (SD)	LCARES (n = 40) M (SD)	P-value
Age	Range: 50–74	56.6 (5.8)	57.7 (6.2)	0.411
Years living in the United Statesa	Range: 2–56	21.7 (10.9)	24.9 (10.8)	0.217
		N (%)	N (%)
Gender	Male	11 (31)	14 (35)	0.681
	Female	25 (69)	26 (65)
Race	Black/African American	1 (3)	0 (0)	0.003
	White	16 (44)	7 (18)
	Otherb	18 (50)	33 (83)
	More than 1 race	1 (3)	0 (0)
Country of birth	United States	4 (11)	1 (3)	0.131
	Other (foreign-born)c	32 (89)	39 (98)
Marital status	Married/living togetherb	24 (67)	29 (73)	0.581
	Divorced/separated	4 (11)	6 (15)
	Widowed	4 (11)	2 (5)
	Never married/single	4 (11)	3 (7)
Employment status	Employedb	21 (58)	19 (49)	0.404
	Not employed	12 (33)	19 (49)
	Retired	2 (5)	1 (2)
	Student	1 (3)	0 (0)
Education	Elementary or less	14 (39)	19 (52)	0.411
	Some HS	10 (28)	4 (11)
	HS graduate	3 (8)	10 (28)
	>HS	9 (25)	7 (19)
Health insurance	No	26 (72)	31 (78)	0.596
	Yes	10 (28)	9 (23)
Income	Less than $10 000	10 (30)	21 (57)	0.026
	$10 000 and greater	23 (70)	16 (43)
SILS-difficulty reading written materialsd	Always difficult	17 (47)	19 (48)	0.981
	Not always difficult	19 (53)	21 (53)
SILS-confidence in completing health formsd	Very confident	26 (72)	31 (78)	0.596
	Less than very confident	10 (28)	9 (23)

N = 76; HS, high school.

Percentage totals may not equal 100% due to rounding and/or missing data.

LCARES versus comparison group differences were evaluated using chi-square for categorical variables and t-test for continuous variables.

^aReflects those born outside the United States (n = 71).

^bFor categorical variables with more than one level, the group comparison was the marked level versus all other levels combined. For the variable ‘Race’, the response of ‘Other’ was selected as the reference because it was the most frequent response category and was used by participants to represent their Latino/Hispanic ethnicity.

^cDistribution by country of birth was: Chile (n = 1), Colombia (n = 6), Costa Rica (n = 3), Cuba (n = 1), Dominican Republic (n = 2), El Salvador (n = 1), Mexico (n = 49), Peru (n = 2), Puerto Rico (n = 5), Venezuela (n = 1) and United States (n = 5). For those born outside the United States, the average number of years in the United States was 23.4 years.

^dSILS, Single Item Literacy Screener. SILS-difficulty reading written materials = self-rated difficulty learning about health condition due to not understanding what is written. SILS-confidence completing health forms = self-rated confidence about filling out health forms.

FIT uptake

FIT kit uptake at 90 days for the entire sample was 87% with 94% of returned FIT kits received within 60 days. FIT kit uptake did not differ significantly by intervention group (P = 0.379) as assessed using logistic regression in a model controlling for race and income. However, uptake in the LCARES group (90%) was higher than that for the comparison group (83%). One participant had an abnormal FIT result (1.5%), and subsequently underwent a diagnostic colonoscopy, with no cancer found.

All variables presented in Tables I and II were evaluated as predictors of uptake using univariate logistic regression. None of the sociodemographic, health literacy and CRC awareness and health belief (PHM) variables predicted FIT kit uptake.

CRC awareness and health beliefs

Table II summarizes health-related beliefs at enrollment and 3-month post-intervention for the 59 participants who completed the follow-up assessment. Change for each variable was evaluated using a 2 (condition) × 2 (time) mixed-design ANOVA. Main effects for time (baseline to post-intervention) were observed for CRC awareness (P < 0.001), PHM response efficacy (P = 0.026), PHM cancer worry (P = 0.005) and PHM self-efficacy (P = 0.039).

Table II.

CRC and CRC screening awareness and health belief variables at baseline and post-intervention follow-up

	Comparison (n = 27)		LCARES (n = 32)
Variable (range)	Baseline M (SD)	Follow-up M (SD)	Baseline M (SD)	Follow-up M (SD)
CRC awareness (0–10)a	5.3 (2.4)	6.4 (2.2)	5.7 (1.9)	7.9 (2.0)
PHM salience and coherence (4–20)	18.9 (1.9)	19.6 (1.0)	19.3 (1.4)	19.3 (1.4)
PHM perceived susceptibility (3–15)b	11.3 (2.4)	10.1 (3.5)	11.3 (2.7)	12.0 (2.6)
PHM response efficacy (2–10)a	9.6 (1.0)	9.8 (0.8)	9.6 (0.9)	9.8 (0.6)
PHM cancer worry (2–10)a,c	6.5 (2.7)	8.3 (2.8)	7.0 (2.3)	7.3 (2.9)
PHM social influence (4–20)	17.8 (2.5)	17.7 (3.5)	18.0 (2.5)	18.2 (3.0)
PHM religious beliefs (5–25)	14.8 (6.0)	14.3 (6.4)	14.0 (6.1)	12.5 (6.7)
PHM self-efficacy (6–30)a,d	29.0 (2.3)	29.5 (1.3)	28.4 (3.3)	29.7 (1.0)

N = 59; PHM, preventive health model; CRC, colorectal cancer.

^aThere was a significant increase in the average from baseline to follow-up. PHM response efficacy and self-efficacy has very high average scores at both baseline and follow-up, with many participants receiving the maximum score. The significant increase over time is then due to those individuals with relatively low scores at baseline having follow-up scores comparable with those who started with a high score.

^bAverage decrease for comparison group is significantly different than average increase for LCARES group.

^cAverage increase for comparison group is significantly greater than for LCARES group.

^dAverage increase for LCARES group is significantly greater than for comparison group.

A significant group × time interaction indicates that the intervention conditions differed in the amount of change. This was found for CRC awareness (P = 0.046) and PHM cancer worry (P = 0.045). As shown in Table II, the average score increased more in the LCARES intervention group for CRC awareness and increased more in the comparison group for PHM cancer worry. A significant interaction was also observed for PHM susceptibility (P = 0.013). There was a non-significant increase in the average score in the LCARES intervention group in contrast to a non-significant decrease in the average score in the comparison group.

Discussion

The current pilot study evaluated a culturally targeted, low-literacy Spanish language educational intervention paired with a FIT kit to determine its preliminary efficacy on FIT uptake. Overall, FIT uptake was 87%, with 90% of participants in the LCARES intervention versus 84% of those in the comparison condition completing FIT. The findings of this pilot study are consistent with two of our previous studies [10, 28] that produced FIT uptake over 80% among participants (in clinic and community settings), rates that exceed both the Healthy People 2020 goal of 70.5% [6] and the National Colorectal Cancer Roundtable goal to reach 80% by 2018 [7]. These FIT uptake rates also exceed the prevailing screening rates at the clinics based on uniform data standard (UDS) measures (66%) and the 48% up-to-date rate (112 out 234) among Hispanic/Latino patients ages 50–75 who were approached for participation in this study. Thus, these preliminary findings lend a foundation for further investigation in future larger efficacy (appropriately powered) and effectiveness trials.

The culturally targeted intervention produced higher FIT uptake than the comparison condition; however, the difference was not statistically significant. The lack of group differences may largely be because of small sample sizes in this pilot trial. It is also possible, as our prior studies suggest [10, 28], that the type of information (i.e. fotonovela/DVD versus narrative brochure) matters less when FIT access is provided. Of note, the LCARES intervention had greater average score increases from baseline to post-intervention for CRC awareness compared with the comparison group. This is similar to a prior study [35] conducted among Latinos that also led to an increase in CRC and screening awareness. In yet another CRC screening study among Latinos [36], providing participants with information via decision aid video helped to increase specific test preference and subsequent ordering of a CRC test. Thus, although future research with larger sample are needed to make a more definitive statement, this study suggests that providing information via small media (i.e. fotonovela or video) may assist patients in gaining knowledge to make an informed decision on screening test. Current study findings also corroborate recently published findings [37] that initial face-to-face interaction may produce greater uptake over other non-personal strategies (e.g. mailings). This could also explain high FIT uptake among both intervention groups and must be further investigated in future research.

Strengths and limitations

This study has several strengths, including addressing a significant public health concern identified by our community. This trial enrolled Latinos from a variety of nationalities who were not up-to-date with CRC screening, and thus, had direct benefit to the 87% of participants who completed FIT screening. Strengths also included the creation of a language-specific intervention (Spanish) for an underserved ethnic group receiving primary care services in a FQHC (a population not typically included in CRC screening trials due to lack of English language proficiency). Albeit not statistically significant, the culturally based and language-specific educational materials produced higher FIT uptake compared with the non-targeted materials in this pilot trial.

Study limitations should also be noted. First, this pilot trial was under-powered which precluded multivariable analyses. In addition, the pilot study was implemented in one clinic organization and in a limited geographic area, potentially reducing generalizability. Furthermore, majority of participants was female; potentially reducing generalizability. Published efforts [29] suggest barriers to male participation may include commonly held beliefs and social norms such as machismo, and male resistance to engage with health research. Future research efforts would benefit from increased male participant recruitment and assessment of factors contributing to increased male access to health systems and participation in research. Nevertheless, this pilot yielded promising data that fosters future research with diverse populations and multi-language interventions among networks of rural and urban FQHCs to increase both reach and generalizability.

Implications for theory, policy and/or practice

The PHM provided relevant theoretical underpinning and organization for the development and implementation of the LCARES intervention which was co-developed in collaboration with a community advisory board along with feedback from intended end-users [29]. As such, future appropriately powered studies will be especially crucial to determine the relevant constructs that may predict CRC screening intention and intervention effectiveness. Regarding policy, the main objective of our intervention study was to address CRC screening disparities among medically underserved Latinos to improve screening rates consistent with Healthy People 2020 goal of 70.5% [6] as well as the National Colorectal Cancer Roundtable goal of 80% by 2018 [7]. Our findings point to a promising intervention strategy (education+FIT) that may help meet these national goals and reduce CRC health disparities. Currently, participating clinic sites have adopted the intervention (education+FIT) among their primary CRC screening strategies within their settings. Future dissemination plans include packaging this intervention and disseminating among all partnering FQHC organizations in our network. A larger scale effectiveness trial is also underway as part of a larger scale multi-level, multi-language longitudinal RCT assessing annual repeat FIT screening in selected FQHCs. Other similar clinical settings wanting to boost CRC uptake can draw from these experiences to develop their practice policies and screening procedures. In terms of practice implications, developers of health education should take into account important patient characteristics such as patient’s preferred language, cultural backgrounds and literacy to ensure that messages can prime patients toward screening decisions. By having clinic providers/staff involved in the developmental of educational tools, we found added endorsement toward the final product. As a result, these portable and easy-to-read materials now serve as helpful educational aids to provider–patient interactions.

Conclusions

The current pilot study showed a high uptake of FIT screening, regardless of group assignment (LCARES 90% versus comparison 83%), consistent with national CRC screening goals of 80% by 2018. Practitioners working in FQHCs and other primary care settings could incorporate face-to-face discussion of FIT (combined with educational information+FIT kit delivery) to boost screening rates. Providing information in preferred language and a format that is appealing and understandable (i.e. fotonovela) may further facilitate communication, and ultimately, may lead to increased screening uptake with the potential to boost UDS measures for CRC screening among FQHCs and contribute toward reducing disparities and meeting national goals. A future study with a larger sample involving multiple FQHCs is recommended to allow exploration of mediators and moderators of intervention effects, and determine subgroups of patients that may benefit the most from this type of intervention strategy. In the long-term, findings of this research support the importance of culturally and linguistically targeted interventions for other ethnic and immigrant communities nationally and worldwide.

Funding

This work was supported by the Florida Department of Health's Biomedical Research Branch, Bankhead Coley [grant number: 4BB09].

Conflict of interest statement

None declared.