Abstract
Background.
Early detection through screening can reduce colorectal cancer (CRC) mortality, but approximately 33% of adults aged 50–75 are not getting screened as recommended. Many interventions to increase CRC screening have been tested, but clinical and community organizations may be challenged in identifying the optimum programs and program materials to increase screening and ultimately reduce CRC mortality.
Methods.
We conducted a scoping review to characterize existing, US-based interventions to improve CRC screening and to identify gaps in the literature. We used t-tests and correlations to analyze the relationship between project features and intervention effect sizes.
Results.
The overall effect sizes were +16% for changes in screening by any modality. The average effect sizes were greater for projects with more components, used patient navigation, and provided free/low-cost testing.
Conclusion.
Interventions varied greatly in terms of follow-up time, test modality, and data sources. Organizations seeking to implement a program aimed at increasing CRC screening should consider both intervention components and relevant program materials.
Keywords: Early detection of cancer, Program evaluation, Colorectal neoplasms, Endoscopy, Occult blood, Review, Evidence-based medicine
Colorectal cancer (CRC) is the second leading cause of cancer death among men and women in the United States.1 It is estimated that 147,950 people in the United States will be diagnosed with, and 53,200 will die from, CRC in 2020.2 In the last fifteen years, CRC incidence and mortality rates have decreased by over 30% among the 50+ age group, with much of the decline being attributed to screening.3 The United States Preventive Services Task Force recommended routine colorectal cancer screening (CRCS) for adults ages 50–75 through endoscopy (e.g., colonoscopy, sigmoidoscopy) or stool tests (e.g., fecal immunochemical test (FIT) and high sensitivity fecal occult blood test (FOBT)). However, approximately 33% of age-eligible adults are not getting screened as recommended.4
Numerous interventions have been developed and tested on their effectiveness in increasing CRCS. Many of these interventions were developed to target specific populations, used different intervention techniques, or assessed different CRCS outcomes. As a result, it may be difficult for organizations interested in using evidence-based practices to increase CRCS in their target populations to assess the replicability and applicability of previous interventions.
The purpose of this study is to use scoping review methods to analyze and compare the effect sizes of various CRCS promotion projects, drawing from peer-reviewed publications and associated intervention resources. We aim to illustrate what factors of the reviewed projects are associated with the greatest improvements in CRCS. Our findings can be used to aid in the identification and selection of appropriate interventions for target communities to increase CRCS and ultimately reduce CRC mortality.
Materials and Methods
We conducted a scoping review5 to characterize and summarize the existing research and identify gaps in the literature about evidence-based intervention projects to promote CRCS. This type of review differs from a systematic review in that a scoping review aims to (1) identify gaps in the literature, (2) provide a general overview of the existing body of literature, and (3) examine general practice of research in a given topic area, while systematic reviews are better used to confirm current practices and highlight conflicting findings in the literature.6 We did not restrict the search by date. We searched the websites for Medline, Google Scholar, American Cancer Society, and the National Cancer Institute (including the Research-Tested Intervention Programs database, rtips.cancer.gov) to identify relevant projects.
For each project, we gathered (1) English-language, peer-reviewed evaluation papers reporting the results of the project, and (2) intervention resources (in any language) to promote CRCS, including flyers, pamphlets, discussion guides, implementation manuals, and videos. We limited the review to studies that were conducted in the United States and evaluated CRCS in at least two arms. We reviewed the reference sections of identified papers to locate additional examples. Several papers made intervention resources available as part of a supplement or online. For projects that did not have intervention resources easily accessible, we emailed the first and/or last author of the paper to request a copy of the resources. For projects with standalone resources, we contacted their authors to inquire about any published evaluation paper. In contrast to previous reviews of CRCS promotion, we aimed to assess aspects of participant-facing educational materials that may impact intervention efficacy. Thus, only projects with both published results and available intervention resources were included in the final analyses. We were able to gather both papers and resources for 13 CRCS promotion projects.7–19
We developed a data abstraction form in REDCap (https://www.project-redcap.org/) to extract relevant features of the projects, including study design and participant characteristics, the role of theory in intervention design and resources, characteristics of CRCS promotional resources, and CRCS outcomes and intervention effects.20 The role of theory was assessed in two ways: (1) through explicit reference to a theory used in project planning or design, and (2) according to study team judgment of health behavior theoretical constructs in intervention resources. Literacy level of the primary resource in each project was calculated with the Flesch-Kincaid grade level calculation.21 Intervention effects were calculated as the absolute percent difference in screening outcomes across different arms/timepoints; due to variation in reporting of effects, these differences were not controlled for by any characteristics of patients, contexts, or interventions. Four study team members (KL, JM, MP, KS) trained on the abstraction form by reviewing four projects and meeting to reconcile findings. After that, each project was reviewed by at least two reviewers. Of the dichotomous fields on the abstraction form, the team achieved interrater reliability of fair to perfect agreement22 across projects (range for Cohen’s kappa=0.29–1.00). Finally, all four of the reviewers met to reconcile findings and achieve consensus for all projects.
We conducted a narrative synthesis to characterize and summarize the features of the CRCS promotion projects. Where possible, we assessed the relationship between project features and intervention effect sizes by conducting t-tests (for dichotomous features) and calculating Pearson’s correlation coefficients (for continuous features). These analyses were conducted in SAS version 9.4 (Cary, NC) using a two-sided p-value of .05.
Results
In total, 13 CRCS promotion projects, with associated papers and resources, were included (Table 1).
Table 1.
First author (year) | Location | Final sample size | Participant characteristics | Study design | Intervention description | Types of components | Effect sizes by study arm | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
Education | Free/low cost screening | Patient navigation | Any modality | Stool tests | Endoscopy | ||||||
Blumenthal et al. (2005) | Tennessee and Georgia, USA | 3914 | Age 18+, African Americans living in predominantly black census tracts in 4 study cities | Community intervention trial | City-wide public events, educational sessions and media messaging to encourage screening and healthy behaviors | X | Tenn.:12%−5% | ||||
Blumenthal et al. (2010) | Georgia, USA | 645 | Age 50+, African American, no history of CRC, no CRC screening test within the recommended time interval | Randomized community intervention trial | Intervention 1: One-on-one education sessions | X | X | Nonsignificant difference from control | |||
Intervention 2: Group education sessions | 16% | ||||||||||
Intervention 3: Financial support | Nonsignificant difference from control | ||||||||||
Braun et al. (2015) | Hawaii, USA | 488 | No age specified, Asian/Pacific Islander Medicare beneficiaries | Randomized controlled trial | Patient navigators assisted with accessing breast, cervical, colorectal, and prostate cancer screening | X | X | 8% | 16% | ||
Coronado et al. (2011) | Washington, USA | 501 | Age 50–79, Hispanic patients, not up-to-date on CRC screening | Individual randomized study | Intervention 1: Mailed FOBT with instructions in English and Spanish along with explanatory photos | X | X | X | 24% | ||
Intervention 2: Same mailed FOBT kit, plus telephone reminders and home visits from community peer educator | 29% | ||||||||||
Denberg et al. (2006) | Colorado, USA | 781 | Age 50+, referred by primary care physician for colonoscopy | Randomized controlled trial | Personalized educational brochure on scheduling, adequate bowel preparation, and risks of screening | X | 12% | ||||
Holt et al. (2013) | Alabama, USA | 316 | Age 50–74, African American, attending one of 16 African-American churches in Birmingham; no history of CRC, able to complete a self-administered questionnaire written at 5th grade reading level | Randomized controlled trial | Spiritually-based educational materials and community health advisor-led group sessions | X | −11% | ||||
Lee et al. (2009) | California, USA | 775 | Age 50+, asymptomatic, veterans | Randomized controlled trial | Mailed reminder to return FOBT; educational materials | X | 16% | ||||
Maxwell et al. (2010) | California, USA | 548 | Age 50–70, Filipino heritage, no history of CRC, out-of-date with CRCS | Community-based randomized trial | Intervention 1: Small-group CRC education session, print take-home materials, reminder letter, and letter to physician | X | 16% | ||||
Intervention 2: All previous components plus a free FOBT kit | 21% | ||||||||||
Percac-Lima et al. (2009) | Massachusetts, USA | 1223 | Age 52–79, out-of-date with CRCS | Randomized controlled trial | Personalized mailing including educational materials; a patient navigator who discussed barriers to screening, options, information on CRC screening, organized scheduling and transportation | X | X | 16% | 11% | ||
Preston et al. (2018) | Arkansas, USA | 330 | Living in rural, poor-resourced counties and out-of-date with CRCS | Randomized controlled trial | Intervention 1: Tailored CRC educational session presented by a community lay health worker using region-specific data | X | X | 3% | |||
Intervention 2: General risk reduction intervention presented by an academic health professional using national data | 17% | ||||||||||
Rice et al. (2017) | New Hampshire, USA | 206 | Age 50–64, income <250% of federal poverty level, scheduled for colonoscopy | Retrospective, nonequivalent comparison group research design | Patient navigation addressing barriers, reviewing instructions, confirming appointments, answering questions, and providing support; free FOBT kit | X | X | X | 27% | ||
Shokar et al. (2016) | Texas, USA | 784 | Age 50–75, uninsured, living in Texas, out-of-date with CRCS | Two arm parallel nonequivalent control group design | Intervention 1: promotora-led health education session | X | X | X | 73% | ||
Intervention 2: Educational novela-style video | 68% | ||||||||||
Intervention 3: Both previous components | 72% | ||||||||||
All groups received free CRCS tests | |||||||||||
Walsh et al. (2010) | California, USA | 1789 | Age 50–79, Latino and Vietnamese primary care patients | Randomized controlled trial | Intervention 1: Mailed FOBT plus culturally-tailored brochures | X | X | X | 7% | ||
Intervention 2: Mailed FOBT plus culturally-tailored brochures and tailored telephone counseling | 17% |
Study design and participant characteristics
Seven projects compared CRCS outcomes in one intervention group, which received promotional resources, against one comparison group that received no treatment, standard of care, or a delayed intervention7,9,11–13,15,17; the remaining projects had additional comparison groups. All projects used educational strategies to increase CRCS; these strategies were coupled with free/low-cost testing (n=6)8,10,16–19 and/or patient navigation (n=6),9,10,15,17–19 among other strategies. On average, projects used 2.7 intervention strategies (range: 1–4).
All thirteen projects took place in the USA7–19 (Table 1). In general, projects targeted adults starting around age 50. Upper age limits were variable, extending into mid-60s, −70s, or up to age 79; five projects had no upper age limit.7–9,11,13 Eight of the projects targeted racial/ethnic minorities.7–10,12,14,18,19
Role of theory in intervention design and resources
Only five papers reported using health behavior theory to inform intervention design,7,12,16,18,19 including Health Belief Model (n=3)7,12,18 and community-based frameworks (n=2).7,16 However, we found evidence of many theoretical constructs in the intervention resources. Almost all resources addressed constructs from the Health Belief Model: barriers to screening (n=12)7–12,14–19 as well as perceived benefits of CRCS and perceived severity and susceptibility to colorectal cancer (n=12).7,8,10–19 Eight projects included resources with a cue to action.7,9–11,13,14,16,19 Fewer projects included resources that addressed self-efficacy,7,12,14,18,19 social norms,7,14,18 or goal-setting.9,14–16
Characteristics of CRCS promotional resources
All projects had print resources promoting CRCS.7–19 All resources were available in English; five also had resources in Spanish,10,15,17–19 and four in other languages (including Filipino, Vietnamese, and Arabic).14,15,17,19 On average, these resources had a 7.8-grade reading level (range: 3.5–9.5).
In addition to print resources, one project also had audio resources,17 and another project included video resources.18 Notably, none of the projects included online resources (beyond references to websites for national public health organizations, e.g., www.cdc.gov).
CRCS outcomes and intervention effects
Project outcomes were diverse in length of follow-up, test modality (e.g., stool test, colonoscopy), data source (e.g., self-report, electronic health record), and analytic approach (e.g., chi-square, regression).
CRCS with any test.
Four papers assessed group-level differences in CRCS by any modality (Table 1).8,14,15,18 Blumenthal et al.8 reported improved CRCS over six months for a group education arm compared to control (+16%, p<.05); two other arms (with one-on-one education or financial assistance) did not differ from control. Maxwell et al.14 reported improved CRCS over six months for two educational intervention arms (with and without free FOBT kits) compared to control (+21% and +16%, respectively, both p<.001). Percac-Lima et al.15 reported improved CRCS over nine months for an education and patient navigation intervention arm compared to control (+16%, p<.001). Shokar et al.18 reported improved CRCS over six months for three intervention arms (offering free stool tests plus (1) promotora assistance, (2) educational video, or (3) promotora assistance and video) compared to control (+73%, +68%, and +72%, respectively, all p<.001).
Nine effect sizes were reported for CRCS by any modality. The median effect size was +16%. Effect sizes were greater for projects that had more components (r=0.84, p<.01), used patient navigation (57% versus 13%, t=3.12, p<.05), targeted Hispanics (71% versus 14%, t=15.51, p<.001), used a behavioral theory (71% versus 14%, t=15.51, p<.001), or targeted self-efficacy or norms (50% versus 11%, t=2.93, p=.04) compared to other projects.
CRCS with stool tests.
Seven papers assessed group-level differences in CRCS with a stool test (FIT or FOBT) (Table 1).7,9,10,12,13,16,19 Three papers reported pre- versus post-test changes by study arm, while five papers reported only follow-up differences by study arm.
Blumenthal et al.7 reported improved pre-/post-test CRCS by stool testing over 18 months for participants in one intervention city versus its comparison city (+12%, p<.01), but not for participants in the other pair of cities, after implementing city-wide education, events, and social marketing campaigns. Braun et al.9 reported improved CRCS over 24 months for an education plus patient navigation arm compared to control receiving education only (+8%, p=.02). Coronado et al.10 reported improved CRCS by stool testing over nine months for two intervention arms (mailed FOBT (1) without versus (2) with sessions with peer community health advisors) compared to control (+24% and +29%, respectively, both p<.001). Holt et al.12 reported reduced CRCS over 12 months for church attendees who received spiritually-based education resources and sessions versus the comparison group of church attendees who received non-spiritually-based resources and sessions (−11%, p=.03).
Lee et al.8 reported improved CRCS over six months for an intervention arm receiving a mailed educational reminder to complete FOBT compared to control (+16%, p<.001). Preston et al.16 reported improved CRCS over two months for an intervention arm receiving general cancer risk reduction education from an academic health professional compared to control (+17%, p<.01); an arm receiving tailored cancer risk reduction education from a community health advisor did not differ from control. Walsh et al.19 reported improved CRCS over 12 months for two arms providing free FOBT kits and culturally-tailored brochures ((1) without and (2) with individually-tailored telephone counseling) compared to control (+7% and +17%, respectively, both p<.01).
Eleven effect sizes were reported for CRCS with stool tests. The median effect size was +12%. Effect sizes were greater for projects that did not target African Americans (15% versus −1%, t=2.54, p=0.03) and projects that did not use the Health Belief Model (15% versus −1%, t=2.54, p=0.03).
CRCS with endoscopy.
Four papers assessed group-level differences in CRCS with endoscopy9,11,15,17 (three reported colonoscopy, and one reported a combined measured of colonoscopy and sigmoidoscopy) (Table 1). Braun et al.9 (described above) reported improved CRCS over 24 months for education plus patient navigation compared to an arm receiving education only (+16%, p<.001). Denberg et al.11 reported improved CRCS by endoscopy over four months for an intervention arm in which participants were mailed an educational brochure within 10 days of referral for colonoscopy compared to a control arm receiving usual care (+12%, p=.001). Percac-Lima et al.15 (described above) reported improved CRCS over nine months for education plus patient navigation compared to control (+11%, p<.001). Rice et al.17 reported improved CRCS over 12 months for education plus patient navigation compared to control (+27%, p<.001).
Four effect sizes were reported for CRCS with endoscopy. The median effect size was +14%. Effect sizes were greater for projects that provided free/low-cost testing compared to other projects (27% versus 13%, t=4.58, p=.04).
Discussion
In this scoping review of 13 evidence-based CRCS promotion projects, we found that interventions varied greatly in terms of follow-up time, test modality, and data sources. The greatest increase in overall effect size was observed in studies that reported changes in CRCS by any modality (median effect size=+16%) or endoscopy (median effect size=+14%). In general, projects had greater effect sizes if they had more components, used patient navigation, or targeted Hispanics.
CRCS promotion project features
Patient navigation was a key component of many of the CRCS projects. Including patient navigation in a CRCS promotion project was associated with greater effect sizes for interventions evaluating changes with any modality. Although six projects used patient navigation, the definition and implementation of patient navigation was not consistent. For example, Shokar et al.18 provided navigation services to all participants, including components such as tracking, reminder calls and letters, appointment scheduling and reminders, assessing individual barriers, and assistance finding healthcare coverage. In comparison, Coronado et al.10 involved a promotora-delivered educational intervention in addition to mailed FOBT cards; the educational intervention included reminder calls and one-on-one support for the participant. Observed effect sizes were much larger for the study by Shokar compared to Coronado,10 but there is no way to know if this variation is due to the design of the patient navigation component. Additional research is needed to further parse which patient navigation services are most influential in increasing cancer screening outcomes.
Another feature we assessed was the use of health behavior theory in program planning or design. Theory-based interventions may undergo a stricter development process during the selection of intervention components, implementation, and outcomes.23 Further, theory-based interventions can be more easily broken down to evaluate intervention effects to determine which components influence intervention outcomes.24 Previous studies have evaluated the use of theory in intervention design and implementation of intervention,25 and suggest that future interventions should be grounded in theory. Compared to projects that did not explicitly use theory, projects that were informed by theory had larger increases in effect sizes for CRCS by any modality; use of Health Belief Model led to decreases in effect sizes for CRCS by stool testing. Different theories were used in different projects, including Health Belief Model7,12,18 and Social Cognitive Theory,18 and some projects used multiple theories while others only used one. Further, it is possible that other projects used behavioral theory in planning or design, but did not describe the theory in the paper. Therefore, it is difficult to draw meaningful conclusions about the role of theory in CRCS promotion projects.
Race/ethnicity was a focus for seven of 13 projects included in the current scoping review. These studies used several strategies to target minority populations, including African-Americans, Hispanics, and Filipinos. First, projects used resources that were tailored and/or translated. For example, Percac-Lima et al.15 employed patient navigators who spoke a combined total of eight languages. Second, the program resources were often culturally-sensitive, including racial representations or culturally-related graphics, which could establish a sense of comfort and belonging among potential participants. Blumenthal et al.7 specifically utilized art that represented African-American ancestral culture along with African-American models portraying different roles. Third, recruitment and outreach activities often took place at community centers, health clinics, or churches where a target population was overrepresented. Holt et al.12 created a faith-based intervention strategy to reach African-Americans, leveraging the central role of the church in many African-American communities. In this review, projects targeting Hispanics had especially large increases in CRCS.
However, we did not find evidence for the efficacy of several project features that we expected to be related to CRCS. We expected to find that printed intervention materials with a lower literacy level would be associated with larger increases in CRCS, since such resources provide more accessible information that could be more effective at changing behaviors, but there was no relationship between literacy and changes in CRCS by any modality, by stool test, or by endoscopy. This finding is consistent with both experimental and observational studies that report only modest or non-significant differences in screening by literacy.26 Further, length of follow-up between study initiation and completion was not correlated with CRCS effect sizes. We expected to see that longer follow-up would be associated with greater CRCS, since participants would have more opportunity to not only complete CRCS, but seek additional information, if needed. Additional studies are needed to further evaluate the role of literacy level and follow-up time in increasing CRCS.
Previous literature
A systematic review of CRCS interventions found certain elements of interventions to be beneficial during program implementation, such as patient navigation and fecal blood test distribution.27 Another review highlighted the beneficial impact of removing financial barriers and using personalized invitation letters to increase CRCS.28 The current review differs from previous literature in that it evaluated both published study outcomes and their associated intervention resources. These findings emphasize the need to better understand the intervention resources themselves, particularly for use when a community organization wants to implement a screening program, for example. The needs of each community are different from one another, and these findings can be used to help decide what resources would be best for their particular population. Findings from existing literature can be used in conjunction with the present findings to develop an intervention aimed at increasing CRCS, with the ability to tailor both intervention structure and the intervention resources to ensure maximum effectiveness. For example, if a community clinic aimed to increase CRCS with any test, they could use the findings from previous reviews to pair (1) free stool tests (based on findings cited above from Dougherty et al. and Senore et al.) with (2) informational materials that emphasize self-efficacy or norms (based on findings from the present study).
Strengths and limitations
The strengths of this review include identifying projects for which both intervention resources and peer-reviewed papers were available, which allowed our team to evaluate outcomes, calculate effect sizes, and assess intervention resources. Our review included projects from diverse settings, making the results more broadly generalizable for future CRCS interventions. In terms of limitations, the included projects were very different from one another, ranging in sample sizes, outcomes, and components, which made it difficult to compare effect sizes and draw conclusions across studies. Another limitation was that we limited our review to projects with both intervention resources and peer-reviewed papers available for review; many additional projects could not be included because we did not have access to both types of materials. Because of these two limitations, the reported overall effect size should be interpreted tentatively. Further, there is some indication of publication bias, since all of the reviewed projects reported positive findings. Thus, we cannot provide insight into what does not work in a CRCS project, which is important to know when designing these interventions. Because all of the projects included took place in the United States, we are unable to make recommendations about interventions delivered internationally.
Gaps in the literature
This scoping review has identified gaps in the literature that should be addressed to better understand what constitutes an effective CRCS intervention. First, none of the reviewed projects included online intervention materials, such as a website or app component. One previous study by Miller et al. (2011) reported increased intentions to screen with the use of a web-based decision aid to increase knowledge of screening test options.29 As technology resources continue to develop and internet access is more readily available, additional research will be needed to evaluate internet-based CRCS promotion components, especially in community settings where access to a clinic may be limited.
Conclusion
Organizations wishing to increase CRCS in their communities can use this research in the development of future interventions. Developing an intervention requires stakeholders to make many decisions, including what sort of intervention components to include, which CRCS modality to promote and evaluate, and how long to follow participants. We found that CRCS projects that used theory-based intervention design had larger improvements in screening using any modality when compared to studies not based on theory. Additionally, studies that used more intervention components, particularly patient navigation, were more successful in increasing CRCS. Overall, our findings highlight that there is no single correct approach to increase screening. Additional research is needed on intervention dimensions such as health literacy and tailoring by race/ethnicity, and future studies should expand CRCS promotion to include web-based components. Through sustained effort, projects aiming to increase CRCS can increased screening, reduce CRC mortality, and ameliorate health disparities.
Highlights.
Overall effect sizes were +16% for changes in screening by any modality
Average effect sizes were greater for projects with more components, used patient navigation, provided free/low cost tests
Interventions varied greatly in terms of follow-up time, test modality, and data sources
New programs aimed at increasing CRC screening should consider both intervention components and relevant program materials
Funding:
Funding for this project came from K22 CA225705 (PI: Moss) and an Institutional Research Grant, IRG-17-175-04, from the American Cancer Society (PI: Moss). In addition, the project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through UL1 TR002014 and UL1 TR00045. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Footnotes
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COI: The authors have no potential conflicts of interest to disclose.
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