Evidence-Based Colorectal Cancer Screening for the Uninsured

NCT01946282 | Completed Results

• 1 other identifier: PP120229 (IRB# 082012-086)
• Study Type: interventional
• Target: 8,565
• Locations: 0 countries
• Sites: N/A

Brief Summary

Through this program, the investigators will test a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. The intervention will consist of mailed screening invitations, with processes such as phone reminders to promote screening and evidence based follow up. All patients will be randomly assigned to receive mailed invitations to complete a home fecal immunochemical test (FIT). Some patients will be randomly assigned to receive a small financial incentive on completion of FIT testing.

Conditions

Colorectal Cancer

Keywords

neoplasm; colorectal; cancer; uninsured; FIT; Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (1)

• FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year

  Primary outcome was analyzed using an intent-to-screen approach where a 2-sided P-value \<0.05 was considered statistically significant. Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. For analysis, incentive groups were combined and compared to outreach alone.

  Each year for three years

Secondary Outcomes (1)

• FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive

  Each year for three years

Study Arms (3)

FIT Invitation Only

ACTIVE COMPARATOR

Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Intervention: Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation. Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.

Other: FIT Invitation Only

FIT plus $5 Incentive

ACTIVE COMPARATOR

Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. Intervention: FIT kits and invitation letter with a $5 gift card incentive to complete screening are mailed to the homes of 1000 randomly assigned eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation. Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.

Other: FIT plus $5 Incentive

FIT plus $10 Incentive

ACTIVE COMPARATOR

Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. Intervention: FIT kits and invitation letter with a $10 gift card incentive to complete screening are mailed to the homes of 1000 randomly assigned eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation. Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.

Other: FIT plus $10 Incentive

Interventions

FIT Invitation Only OTHER

Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls.

Also known as: POLYMEDCO Fecal Immunochemical Test (FIT), John Peter Smith Health System

FIT Invitation Only

FIT plus $5 Incentive OTHER

Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.

Also known as: POLYMEDCO Fecal Immunochemical Test (FIT), John Peter Smith Health System

FIT plus $5 Incentive

FIT plus $10 Incentive OTHER

Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.

Also known as: POLYMEDCO Fecal Immunochemical Test (FIT)

FIT plus $10 Incentive

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 50-64.
• Uninsured, but participants in John Peter Smith Health System (JPS) medical assistance program for the uninsured.
• One or more visits to a JPS primary care clinic within a year.
• Not up-to-date with colorectal cancer screening.

You may not qualify if:

• Patients with a history of Colorectal Cancer or colon resection, no address and/or phone number on file, or who are incarcerated will be excluded.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator

Related Publications (13)

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  PMID: 20610543 BACKGROUND

• StatBite: National Costs for Cancer Care in 2010 in Billions of Dollars by Cancer Site. J Natl Cancer Inst. 2012 Jan 4;104(1):13. doi: 10.1093/jnci/djr534. Epub 2011 Dec 14. No abstract available.

  PMID: 22173584 BACKGROUND

• Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A. Association of insurance with cancer care utilization and outcomes. CA Cancer J Clin. 2008 Jan-Feb;58(1):9-31. doi: 10.3322/CA.2007.0011. Epub 2007 Dec 20.

  PMID: 18096863 BACKGROUND

• Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.

  PMID: 8942775 BACKGROUND

• Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993 May 13;328(19):1365-71. doi: 10.1056/NEJM199305133281901.

  PMID: 8474513 BACKGROUND

• Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7.

  PMID: 8942774 BACKGROUND

• Faivre J, Dancourt V, Lejeune C, Tazi MA, Lamour J, Gerard D, Dassonville F, Bonithon-Kopp C. Reduction in colorectal cancer mortality by fecal occult blood screening in a French controlled study. Gastroenterology. 2004 Jun;126(7):1674-80. doi: 10.1053/j.gastro.2004.02.018.

  PMID: 15188160 BACKGROUND

• Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.

  PMID: 20430429 BACKGROUND

• Kahi CJ, Imperiale TF, Juliar BE, Rex DK. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol. 2009 Jul;7(7):770-5; quiz 711. doi: 10.1016/j.cgh.2008.12.030. Epub 2009 Jan 11.

  PMID: 19268269 BACKGROUND

• Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer after colonoscopy: a population-based, case-control study. Ann Intern Med. 2011 Jan 4;154(1):22-30. doi: 10.7326/0003-4819-154-1-201101040-00004.

  PMID: 21200035 BACKGROUND

• Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.

  PMID: 19075198 BACKGROUND

• Jetelina KK, Yudkin JS, Miller S, Berry E, Lieberman A, Gupta S, Balasubramanian BA. Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients. J Gen Intern Med. 2019 Sep;34(9):1730-1736. doi: 10.1007/s11606-019-05117-0. Epub 2019 Jun 21.

  PMID: 31228053 DERIVED

• Berry E, Miller S, Koch M, Balasubramanian B, Argenbright K, Gupta S. Lower Abnormal Fecal Immunochemical Test Cut-Off Values Improve Detection of Colorectal Cancer in System-Level Screens. Clin Gastroenterol Hepatol. 2020 Mar;18(3):647-653. doi: 10.1016/j.cgh.2019.04.077. Epub 2019 May 11.

  PMID: 31085338 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

We focused exclusively on an uninsured low-income population and offered relatively modest incentives. Thus, our results may not be generalizable to other populations or incentive amounts.

Results Point of Contact

• Title: Dr. Keith Argenbright, Director, Moncrief Cancer Institute
• Organization: University of Texas Southwestern Medical Center, Moncrief Cancer Institute

keith.argenbright@utsouthwestern.edu

817-288-0070

Study Officials

• Keith Argenbright, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Samir Gupta, M.D.

  University of California, San Diego

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 19, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share