Health Literacy Interventions to Overcome Disparities in CRC Screening

In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual colorectal cancer (CRC) screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of this study is to compare the effectiveness of two distinct follow-up strategies to promote CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2. Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both follow-up strategies to investigate implementation and barriers 4. Determine if the effects of either strategy vary by patients' literacy skills. 5. Explore patient characteristics associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time between study arms.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: automated telephone reminder; Behavioral: Health literacy appropriate education and demonstration; Behavioral: prevention coordinator

Detailed Description

The investigators objective is to compare the effectiveness of two distinct follow-up strategies to promote colorectal cancer screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project [R01CA115869] by adding a follow-up strategy to the health literacy intervention. In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual CRC screening using Fecal Immunochemical Test (FIT).

Substantial evidence shows that routine screening can prevent colorectal cancer (CRC) or detect it at an early stage, reducing related mortality. While overall CRC screening rates in the US are increasing, rates remain persistently low among uninsured and low-income individuals, those with fewer years of education, and racial/ethnic minorities. Low health literacy has been linked to cancer screening noncompliance, higher rates of advanced stage of presentation of disease and health disparities. In response, the Department of Health and Human Services has called for health information and services that are accurate, accessible, and actionable as well as culturally appropriate.

This study will implement a two-arm, randomized controlled trial with low income, underinsured patients in federally qualified health centers (FQHCs) to evaluate and compare the effectiveness of PC and ATR follow-up strategies to increase CRC screening. All patients recruited to the study will receive evidence-based, literacy appropriate screening materials developed using health literacy 'best practices' and a simplified FIT kit. Use of these materials has been shown to significantly increase CRC screening rates in the investigators ongoing study. Patients will be randomized to receive either: 1) the PC follow-up strategy, in which a PC personally reminds patients to complete and mail FIT kits, and perceived barriers to screening are discussed and addressed; or 2) the ATR follow-up strategy, in which an automated system electronically encourages patients to complete and mail FIT kits using plain language messages. The effectiveness of these two approaches will be compared at 12 and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 620
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • LSU Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. a patient of the identified clinics,
2. age 50 to 75 (based on American Cancer Society (ACS) guidelines), and
3. can speak and understand English

Exclusion Criteria:

1. previous history of cancer other than non-melanoma skin cancer,
2. up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),
3. a first relative family history that requires a more complete history and possible colonoscopy because of their risk factor (these patients will be referred to their provider for follow-up),
4. an uncorrectable hearing or visual impairment, or
5. too ill to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: automated telephone reminder arm; Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.	Behavioral: automated telephone reminder; The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.; Behavioral: Health literacy appropriate education and demonstration; The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.
Active Comparator: prevention coordinator arm; Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.	Behavioral: Health literacy appropriate education and demonstration; The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.; Behavioral: prevention coordinator; The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial CRC Screening	A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.	6 months after receipt of FIT kit
Repeat CRC Screening	Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 2 primary outcome is number of participants who return a FIT for 2 years.	between 12 and 18 months of previous screen, 2 years overall
Repeat Screening	Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 3 primary outcome is number of participants who return a FIT all 3 years.	between 12 and 18 months of previous screen, 2 years overall

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborators: Northwestern University; Loyola University

Publications and helpful links

General Publications

• Church TR, Yeazel MW, Jones RM, Kochevar LK, Watt GD, Mongin SJ, Cordes JE, Engelhard D. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004 May 19;96(10):770-80. doi: 10.1093/jnci/djh134.
• Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. 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. Gastroenterology. 2008 May;134(5):1570-95. doi: 10.1053/j.gastro.2008.02.002. Epub 2008 Feb 8.
• Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.
• Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Keating NL, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. National Institutes of Health state-of-the-science conference statement: Enhancing use and quality of colorectal cancer screening. Ann Intern Med. 2010 May 18;152(10):663-7. doi: 10.7326/0003-4819-152-10-201005180-00237. Epub 2010 Apr 13. No abstract available.
• Taplin SH, Haggstrom D, Jacobs T, Determan A, Granger J, Montalvo W, Snyder WM, Lockhart S, Calvo A. Implementing colorectal cancer screening in community health centers: addressing cancer health disparities through a regional cancer collaborative. Med Care. 2008 Sep;46(9 Suppl 1):S74-83. doi: 10.1097/MLR.0b013e31817fdf68.
• Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening among adults aged 50-75 years - United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Jul 9;59(26):808-12.
• Davis TC, Dolan NC, Ferreira MR, Tomori C, Green KW, Sipler AM, Bennett CL. The role of inadequate health literacy skills in colorectal cancer screening. Cancer Invest. 2001;19(2):193-200. doi: 10.1081/cnv-100000154.
• Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health literacy and cancer communication. CA Cancer J Clin. 2002 May-Jun;52(3):134-49. doi: 10.3322/canjclin.52.3.134.
• Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.
• Burt RW. Strategies for colon cancer screening with considerations of cost and access to care. J Natl Compr Canc Netw. 2010 Jan;8(1):2-5. doi: 10.6004/jnccn.2010.0002. No abstract available.
• O'Malley AS, Beaton E, Yabroff KR, Abramson R, Mandelblatt J. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Prev Med. 2004 Jul;39(1):56-63. doi: 10.1016/j.ypmed.2004.02.022.
• Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
• Greiner KA, Born W, Nollen N, Ahluwalia JS. Knowledge and perceptions of colorectal cancer screening among urban African Americans. J Gen Intern Med. 2005 Nov;20(11):977-83. doi: 10.1111/j.1525-1497.2005.00165.x.
• Davis TC, Arnold CL, Rademaker AW, Platt DJ, Esparza J, Liu D, Wolf MS. FOBT completion in FQHCs: impact of physician recommendation, FOBT information, or receipt of the FOBT kit. J Rural Health. 2012 Summer;28(3):306-11. doi: 10.1111/j.1748-0361.2011.00402.x. Epub 2012 Jan 24.
• Arnold CL, Rademaker A, Bailey SC, Esparza JM, Reynolds C, Liu D, Platt D, Davis TC. Literacy barriers to colorectal cancer screening in community clinics. J Health Commun. 2012;17 Suppl 3(0 3):252-64. doi: 10.1080/10810730.2012.713441.
• Khankari K, Eder M, Osborn CY, Makoul G, Clayman M, Skripkauskas S, Diamond-Shapiro L, Makundan D, Wolf MS. Improving colorectal cancer screening among the medically underserved: a pilot study within a federally qualified health center. J Gen Intern Med. 2007 Oct;22(10):1410-4. doi: 10.1007/s11606-007-0295-0. Epub 2007 Jul 26.
• Baron RC, Melillo S, Rimer BK, Coates RJ, Kerner J, Habarta N, Chattopadhyay S, Sabatino SA, Elder R, Leeks KJ; Task Force on Community Preventive Services. Intervention to increase recommendation and delivery of screening for breast, cervical, and colorectal cancers by healthcare providers a systematic review of provider reminders. Am J Prev Med. 2010 Jan;38(1):110-7. doi: 10.1016/j.amepre.2009.09.031.
• Zapka J. Innovative provider- and health system-directed approaches to improving colorectal cancer screening delivery. Med Care. 2008 Sep;46(9 Suppl 1):S62-7. doi: 10.1097/MLR.0b013e31817fdf57. No abstract available.
• Roetzheim RG, Christman LK, Jacobsen PB, Cantor AB, Schroeder J, Abdulla R, Hunter S, Chirikos TN, Krischer JP. A randomized controlled trial to increase cancer screening among attendees of community health centers. Ann Fam Med. 2004 Jul-Aug;2(4):294-300. doi: 10.1370/afm.101.
• Myers RE, Sifri R, Hyslop T, Rosenthal M, Vernon SW, Cocroft J, Wolf T, Andrel J, Wender R. A randomized controlled trial of the impact of targeted and tailored interventions on colorectal cancer screening. Cancer. 2007 Nov 1;110(9):2083-91. doi: 10.1002/cncr.23022.
• Stokamer CL, Tenner CT, Chaudhuri J, Vazquez E, Bini EJ. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med. 2005 Mar;20(3):278-82. doi: 10.1111/j.1525-1497.2005.40023.x.
• Pignone M, DeWalt DA, Sheridan S, Berkman N, Lohr KN. Interventions to improve health outcomes for patients with low literacy. A systematic review. J Gen Intern Med. 2005 Feb;20(2):185-92. doi: 10.1111/j.1525-1497.2005.40208.x.
• Steele RJ, Kostourou I, McClements P, Watling C, Libby G, Weller D, Brewster DH, Black R, Carey FA, Fraser C. Effect of repeated invitations on uptake of colorectal cancer screening using faecal occult blood testing: analysis of prevalence and incidence screening. BMJ. 2010 Oct 27;341:c5531. doi: 10.1136/bmj.c5531.
• DeFrank JT, Rimer BK, Gierisch JM, Bowling JM, Farrell D, Skinner CS. Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial. Am J Prev Med. 2009 Jun;36(6):459-67. doi: 10.1016/j.amepre.2009.01.032. Epub 2009 Apr 11.
• Lee JK, Reis V, Liu S, Conn L, Groessl EJ, Ganiats TG, Ho SB. Improving fecal occult blood testing compliance using a mailed educational reminder. J Gen Intern Med. 2009 Nov;24(11):1192-7. doi: 10.1007/s11606-009-1087-5. Epub 2009 Sep 23.
• Mosen DM, Feldstein AC, Perrin N, Rosales AG, Smith DH, Liles EG, Schneider JL, Lafata JE, Myers RE, Kositch M, Hickey T, Glasgow RE. Automated telephone calls improved completion of fecal occult blood testing. Med Care. 2010 Jul;48(7):604-10. doi: 10.1097/MLR.0b013e3181dbdce7.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer screening; low literacy; community clinics; Fecal Immunochemical Test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RSG-13-021-01 - CPPB (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No