Abstract
Purpose
To determine the return rate of community-delivered fecal immunochemical test (FIT) kits in a rural population and to identify significant predictors of returning kits.
Methods
Residents were recruited in 8 rural Kentucky counties to enroll in the study and receive an FIT kit. Of 345 recruited, 82.0% returned an FIT kit from the point of distribution. These participants were compared to the remainder relative to age, sex, marital status, having an annual income below $15,000, not graduating from high school, not having a regular health care provider, not having health care coverage, being a current smoker, indicating current overweight or obese status, and a scale measure of fatalism pertaining to colorectal cancer. Predictors achieving significance at the bivariate level were entered into a stepwise logistic regression model to calculate adjusted OR and 95% CI.
Findings
The return rate was 82.0%. In adjusted analyses, those indicating an annual income of less than $15,000 were 2.85 times more likely to return their kits (95% CI: 1.56–5.24; P < .001). Also, those not perceiving themselves to be overweight/obese were 1.95 times more likely to return their kits (95% CI: 1.07–3.55; P = .029).
Conclusions
An outreach-based colorectal cancer screening program in a rural population may yield high return rates. People with annual incomes below $15,000 and those not having perceptions of being overweight/obese may be particularly likely to return FIT kits.
Keywords: access to care, colorectal cancer screening, epidemiology, fecal immunochemical testing, health disparities
Colorectal cancer (CRC) is the second leading cause of cancer mortality in the United States and the second most common site of new cases of cancer in men and women.1 The burden of CRC disproportionately falls on rural Americans.2,3 Because CRC often is preceded by an adenoma, there is ample opportunity to prevent malignancy through screening.4 Identification of early-stage cancers and precursor lesions that can be removed has led to a consistent decline in CRC incidence and mortality rates over the past 20 years.5
The Guide to Community Preventive Services indicates that there is a need for further efficacy testing of interventions that reduce barriers to CRC screening. In particular, the guide recommends the use of fecal occult blood testing (FOBT) in “alternative settings or nonclinical settings.”6 A new form of FOBT, the fecal immunochemical test (FIT), presents some advantages over older tests because it does not require dietary or drug restrictions, and sample collection may involve less effort. Furthermore, FIT has demonstrated improved specificity over FOBT tests.4.
FIT represents a novel approach to enhancing CRC screening, particularly in rural regions that lack health care access, as it lends itself to organized CRC screening programs. For example, a UK study mailed FOBT tests to patients aged 50–69.7 Of the nearly 500,000 mailed FOBTs, 57% were returned. Similar but smaller studies have occurred in the United States.4,8,9 However, studies have not assessed the utility of using a community-based outreach approach that involves direct staff contact with potential users of an FIT kit. Several forms of preliminary research are needed before this type of program is ready for widespread use, one of which is the determination of the rate of return. A second priority should be to determine who is most likely to return (and not return) kits. Given the multiple advantages of FIT,10 and of using community outreach for rural Americans, we addressed this research question with that population as our target. Accordingly, the purpose of this study was 2-fold: (1) to determine the return rate of FIT kits provided to rural residents through direct contact and (2) to identify factors that predict the return of FIT kits.
Methods
Study Sample
Residents (N = 345) were recruited in 8 rural Kentucky counties to enroll in the study and receive an FIT kit, yielding a participation rate of 90.7%. Recruitment occurred in 8 economically distressed counties of rural Appalachia. Based on rural-urban commuting area codes,11 7 of these counties were ranked extremely rural (code of 10), with 1 being ranked less extreme in its rural classification (ie, code of 8). Eligibility criteria were: (1) being between 50 and 75 years of age (however, those 30 and older with a first-degree relative previously diagnosed with CRC were also eligible) and (2) reporting a previous CRC screening history that is not compliant with recommendations.
Recruitment methods included flyers posted in local health departments. Flyers described the FIT kit as a test to screen for CRC and noted that people enrolling in this study would be compensated for their time. Staff were trained to describe the FIT kit as a simple at-home test that can determine the presence of precancerous polyps. Participants were also recruited at community outreach events. Direct referrals were provided by local health departments. Additionally, project staff conducted outreach to senior citizen centers throughout the 8-county area and at health and wellness events sponsored by local employers.
Procedures
Participants completed a paper-and-pencil survey instrument prior to receiving instructions for specimen collection. Survey questions collected demographic and health information. All study procedures were approved by the Office of Research Integrity at the University of Kentucky.
Measures
A 4-item scale assessed perceptions of fatalism regarding CRC. Items were: (1) “I am likely to develop colorectal cancer in my lifetime,” (2) “I am worried that I will develop colorectal cancer in my lifetime,” (3) “If it was meant for me to develop colorectal cancer there is nothing that I can do about it,” and (4) “There is nothing I can do to reduce my risk of developing colorectal cancer.” The scale produced an excellent interitem reliability coefficient (Cronbach’s alpha = .93). This measure has been tested and used previously with populations of rural Appalachians.12
Data Analysis
Associations between dichotomous correlates and return of FIT kits were tested using chi-square tests. Associations between continuous correlates and return were tested by independent group t tests. Correlates obtaining significance at the bivariate level were entered into a stepwise logistic regression model to calculate adjusted OR and their 95% CI.
Results
Of 345 participants, 82.0% returned an FIT kit to a staff member. The average age of the sample was 57.2 years (SD = 11.07 years). The range was 30 to 75 years of age. Most (68.4%) were female. Nearly all of the participants identified as white, except 3 who identified as black and 2 identifying as Native American. Just under one-half of the sample (45.8%) was currently married. Most (69.6%) had graduated from high school. About one-third (32.3%) were covered by Medicaid and 38.4% were Medicare beneficiaries.
Bivariate Associations
Table 1 displays the bivariate associations between the dichotomous correlates and the return of FIT kits. As shown, 4 of the 8 correlates obtained significance. Those indicating an annual income of less than $15,000 per year were more likely to return the kits (89.8%) than those earning more than this amount (73.8%). Also, those indicating they did not have a regular health care provider were more likely to return their kits (92.3%) compared with those who indicated having a regular provider (79.9%). Persons rating themselves as overweight or obese were less likely to return kits (76.4%) than those not having this perception of their weight (87.3%). Finally, people who did not graduate from high school were more likely to return their kits (88.6%) than those with at least a high school education (79.2%).
Table 1.
Correlate | Percent Returning Kit | P | |
---|---|---|---|
Personal income is less than $15,000 annually | |||
No | (n = 168) | 73.8 | |
Yes | (n = 177) | 89.8 | <.001 |
Has graduated from high school | |||
No | (n = 105) | 88.6 | |
Yes | (n = 240) | 79.2 | .036 |
Sex | |||
Male | (n = 108) | 84.3 | |
Female | (n = 236) | 80.9 | .68 |
Currently married | |||
No | (n = 187) | 84.5 | |
Yes | (n = 158) | 79.1 | .19 |
Currently smoke | |||
No | (n = 220) | 80.9 | |
Yes | (n = 119) | 84.0 | .47 |
Currently overweight or obese | |||
No | (n = 166) | 87.3 | |
Yes | (n = 174) | 76.4 | .009 |
Has some form of medical insurance | |||
No | (n = 31) | 77.4 | |
Yes | (n = 309) | 82.5 | .48 |
Has a regular health care provider | |||
No | (n = 65) | 92.3 | |
Yes | (n = 274) | 79.9 | .019 |
Table 2 displays the bivariate associations between the 2 continuous correlates and the return of FIT kits. As shown, neither age nor the scale measure of CRC fatalism was associated with return of FIT kits.
Table 2.
Correlate | Mean/Returning Kit | Mean/Not Returning | t | df | P |
---|---|---|---|---|---|
Age | 57.3 | 56.7 | .42 | 343 | .68 |
Fatalisma | 9.13 | 8.43 | 1.44 | 332 | .15 |
The overall SD for this scale was 3.4.
Multivariate Associations
The multivariate model achieved significance (χ2 = 191.4, 2 df, P < .001) and had adequate Goodness of Fit (χ2 = 1.43, 2 df, P = .49). The final model included only 2 correlates. Those indicating an annual income of less than $15,000 were 2.85 times more likely to return their kits (95% CI: 1.56–5.24; P < .001). Also, those not perceiving themselves to be overweight/obese were 1.95 times more likely to return their kits (95% CI: 1.07–3.55; P = .029). Not having a regular health care provider (P = .06) and not graduating from high school (P = .49) were not retained in the final iteration of the model.
Discussion
These findings suggest that an outreach-based CRC screening program may yield high return rates when people can interface with staff members initially providing the kits to them. This level of personal contact may be important in rural populations. Whether taking this “personal connection” out of the distribution model (such as would be the case if people were expected to return the kits only by US mail) would substantially reduce the return rate is an empirical question worthy of future investigation. Persons who have low incomes and lack a regular health care provider may be particularly likely to return kits, as are those who lack a high school education and consider themselves as not being overweight or obese. In the adjusted analysis, it was further shown that only low income and perceptions of not being overweight/obese were the primary predictors of FIT kit return.
The observed return rate exceeded that found in past studies,13,14 including studies of FOBT kits.15–19 One key difference between this study and these past studies is that our participants were recruited through community outreach, as opposed to recruiting clinic patients.
Regarding the finding that people with relatively lower incomes were more likely to return an FIT kit, one possible reason for this may involve the sense of gaining something without financial cost. Indeed, the Structural Model of Health Behavior1,20 suggests that simply making an innovation such as an FIT kit easily and freely available may be an adequate intervention in its own right.
As for the finding regarding those self-reporting as not being overweight or obese being more likely to return an FIT kit, this phenomenon may be attributable to a concept included in the transactional model of stress and coping.21 This model suggests that screening behaviors, for example, are predicted by a person’s perceived self-efficacy for coping with a potential positive diagnosis (emotional coping) and their perceived self-efficacy for physically coping with a positive diagnosis. To the extent people know that being overweight or obese creates added risk for CRC, it is possible that these individuals may not be emotionally or physically prepared to potentially receive the news that they have a positive result on an FIT test, thus suggesting the need for further evaluation and possible cancer.
Limitations
Our findings are limited by the use of a convenience sample. Furthermore, generalization of the study findings to other underserved, rural populations is not possible. Also, our selection of covariates was limited; clearly, unmeasured confounding may have occurred.
Conclusions
The prevailing strategy for promoting CRC screening is embedded in the medical paradigm of serving patients in clinics. A community-based approach to delivering FIT kits challenges the assumptions underlying current CRC screening methods, and an in-person, community-based screening program may have important implications for isolated populations with limited access to health care. This low-intensity, low-resource service delivery intervention transcends geography and the limitations of rural health care systems. A key challenge will be boosting return rates among those who are not classified as low-income and among those who perceive themselves to be overweight or obese.
Acknowledgments
Funding: Funding for this research and the ensuing journal article is from the Centers for Disease Control and Prevention – Cooperative Agreement Number 1U48 DP005014. The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Furthermore, the views expressed do not necessarily reflect the official policies of the Department of Health and Human Services, nor does the mention of trade names, commercial practices, or organizations imply endorsement by the US government.
References
- 1.US Cancer Statistics Working Group. [Accessed April 20, 2014];United States Cancer Statistics (USCS) 1999–2010 Cancer Incidence and Mortality Data, Centers for Disease Control and Prevention. 2013 Available at: http://apps.nccd.cdc.gov/uscs/
- 2.Paskett ED, Fisher JL, Lengerich EJ, et al. Disparities in underserved white populations: the case of cancer-related disparities in Appalachia. Oncologist. 2011;16(8):1072–1081. doi: 10.1634/theoncologist.2011-0145. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Cole AM, Jackson JE, Doescher M. Urban-rural disparities in colorectal cancer screening: cross-sectional analysis of 1998–2005 data from the Centers for Disease Control’s Behavioral Risk Factor Surveillance Study. Cancer Med. 2012;1(3):350–356. doi: 10.1002/cam4.40. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Levin B, Lieberman DA, McFarland B, et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA-Cancer J Clin. 2008;58(3):130–160. doi: 10.3322/CA.2007.0018. [DOI] [PubMed] [Google Scholar]
- 5.Pignone M, Teutsch RM, Berg AO, Lohr KN. Screening for colorectal cancer in adults at average risk: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002;137(2):132–141. doi: 10.7326/0003-4819-137-2-200207160-00015. [DOI] [PubMed] [Google Scholar]
- 6.The Guide to Community Preventive Services. [Accessed April 15, 2014];Increasing Cancer Screening: Reducing Structural Barriers for Clients. 2010 Available at: http://www.thecommunityguide.org/cancer/screening/client-oriented/ReducingStructuralBarriers.html.
- 7.UK Colorectal Cancer Screening Pilot Group. Results of the first round of a demonstration pilot of screening for colorectal cancer in the United Kingdom. Br Med J (Clin Res Ed) 2004;329(7458):e133. doi: 10.1136/bmj.38153.491887.7C. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Levin TR. Optimizing colorectal cancer screening by getting FIT right. Gastroenterology. 2011;141(5):1551–1555. doi: 10.1053/j.gastro.2011.09.021. [DOI] [PubMed] [Google Scholar]
- 9.Gupta S, Halm EA, Rockey DC, 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: Int Med. 2013;173(18):1725–1732. doi: 10.1001/jamainternmed.2013.9294. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Guy GP, Richardson LC, Pigone MP, Plescia M. Costs and benefits of an organized fecal immunochemical test-based colorectal cancer screening program in the United States. Cancer. 2014;120(15):2308–2315. doi: 10.1002/cncr.28724. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Rural Health Research Association. [Accessed July 18, 2016];Rural-Urban Area Commuting Codes. Available at: http://depts.washington.edu/uwruca/
- 12.Vanderpool RC, Van Meter E, Stradtman LR, Crosby RA. Fatalistic beliefs and completion of the HPV vaccination series among a sample of young Appalachian Kentucky women. J Rural Health. 2015;31:199–205. doi: 10.1111/jrh.12102. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Liles EG, Perrin N, Rosales AG, et al. Change to FIT increased CRC screening rates: evaluation of a US screening outreach program. Am J Manag C. 2012;18(10):588–595. [PMC free article] [PubMed] [Google Scholar]
- 14.Levy BT, Daly JM, Xu YH, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012;25(1):73–82. doi: 10.3122/jabfm.2012.01.110055. [DOI] [PubMed] [Google Scholar]
- 15.Myers RE, Ross EA, Wolf TA, Balshem A, Jepson C, Millner L. Behavioral interventions to increase adherence in colorectal cancer screening. Med Care. 1991;29(10):1039–1050. doi: 10.1097/00005650-199110000-00009. [DOI] [PubMed] [Google Scholar]
- 16.Myers RE, Sifri R, Hyslop T, et al. A randomized controlled trial of the impact of targeted and tailored interventions on colorectal cancer screening. Cancer. 2007;110(9):2083–2091. doi: 10.1002/cncr.23022. [DOI] [PubMed] [Google Scholar]
- 17.Hart AR, Barone TL, Gay SP, et al. The effect on compliance of a health education leaflet in colorectal cancer screening in general practice in central England. J Epidemiol Commun H. 1997;51(2):187–191. doi: 10.1136/jech.51.2.187. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Walsh JM, Karliner L, Burke N, Somkin CP, Pham LA, Pasick R. Physicians’ approaches to recommending colorectal cancer screening: a qualitative study. J Cancer Educ. 2010;25(3):385–390. doi: 10.1007/s13187-010-0058-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Daly JM, Levy BT, Merchant ML, Wilbur J. Mailed fecal-immunochemical test for colon cancer screening. J Commun Health. 2010;35(3):235–239. doi: 10.1007/s10900-010-9227-8. [DOI] [PubMed] [Google Scholar]
- 20.Cohen DA, Scribner RA, Farley TA. A structural model of health behavior: a pragmatic approach to explain and influence health behaviors at the population level. Prev Med. 2000;30:146–154. doi: 10.1006/pmed.1999.0609. [DOI] [PubMed] [Google Scholar]
- 21.Lazarus RS, Folkman S. Stress, Appraisal, and Coping. New York: Springer; 1984. [Google Scholar]