Health Literacy Interventions to Overcome Disparities in CRC Screening

NCT02360605 | Completed Results DMC

• 1 other identifier: RSG-13-021-01 - CPPB
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer screening; low literacy; community clinics; Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

automated telephone reminder arm

ACTIVE COMPARATOR

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; Behavioral: Health literacy appropriate education and demonstration

prevention coordinator arm

ACTIVE COMPARATOR

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: prevention coordinator; Behavioral: Health literacy appropriate education and demonstration

Interventions

automated telephone reminder BEHAVIORAL

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.

automated telephone reminder arm

prevention coordinator BEHAVIORAL

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.

prevention coordinator arm

Health literacy appropriate education and demonstration BEHAVIORAL

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.

automated telephone reminder arm; prevention coordinator arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous history of cancer other than non-melanoma skin cancer,
• up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),
• 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),
• an uncorrectable hearing or visual impairment, or
• too ill to participate.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• Northwestern University: collaborator
• Loyola University: collaborator

Study Sites (1)

LSU Health Sciences Center

Shreveport, Louisiana, 71130, United States

Location

Related Publications (26)

• 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.

  PMID: 18384785 BACKGROUND

• 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.

  PMID: 19998273 BACKGROUND

• 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.

  PMID: 20388702 BACKGROUND

• 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.

  PMID: 18725837 BACKGROUND

• 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.

  PMID: 20613704 BACKGROUND

• 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.

  PMID: 11296623 BACKGROUND

• 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.

  PMID: 12018928 BACKGROUND

• 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.

  PMID: 15226329 BACKGROUND

• 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.

  PMID: 20064288 BACKGROUND

• 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.

  PMID: 15207986 BACKGROUND

• 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.

  PMID: 18304342 BACKGROUND

• 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.

  PMID: 16307620 BACKGROUND

• 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.

  PMID: 22757955 BACKGROUND

• 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.

  PMID: 23030574 BACKGROUND

• 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.

  PMID: 17653808 BACKGROUND

• 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.

  PMID: 20117566 BACKGROUND

• 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.

  PMID: 18725835 BACKGROUND

• 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.

  PMID: 15335126 BACKGROUND

• 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.

  PMID: 17893869 BACKGROUND

• 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.

  PMID: 15836533 BACKGROUND

• 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.

  PMID: 15150305 BACKGROUND

• 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.

  PMID: 15836553 BACKGROUND

• 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.

  PMID: 20980376 BACKGROUND

• 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.

  PMID: 19362800 BACKGROUND

• 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.

  PMID: 19774423 BACKGROUND

• 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.

  PMID: 20508529 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Connie Arnold
• Organization: LSUShreveport

carnol@lsuhsc.edu

318-675-4324

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 10, 2015
• Study Start: February 1, 2015
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: June 30, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)