Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

NCT01477814 | Completed

• 1 other identifier: 200805728
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?

Conditions

Colorectal Cancer

Keywords

colorectal cancer; screening; colonoscopy; fecal immunochemical test; clinical guidelines

Outcome Measures

Primary Outcomes (1)

• colorectal cancer screening

  The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods

  15 months

Secondary Outcomes (1)

• cost-effectiveness of various strategies for screening

  15 months

Study Arms (3)

physician chart reminder

ACTIVE COMPARATOR

either a paper or an electronic reminder placed on the subject's medical record to remind the physician to screen for colorectal cancer

Behavioral: Physician chart reminder

chart reminder, educational mat'ls, FIT

ACTIVE COMPARATOR

physician chart reminder plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test

Behavioral: Physician chart reminder; Behavioral: chart reminder, educational mat'ls, FIT

CR, ed mat'ls, FIT, phone call

ACTIVE COMPARATOR

physician chart reminder (CR) plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test, and a motivational telephone call designed to elicit barriers and preferences and motivate individuals to complete a CRC screening test.

Behavioral: Physician chart reminder; Behavioral: CR,ed mat'ls, FIT, phone call

Interventions

Physician chart reminder BEHAVIORAL

Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening

Also known as: chart reminder

CR, ed mat'ls, FIT, phone call; chart reminder, educational mat'ls, FIT; physician chart reminder

chart reminder, educational mat'ls, FIT BEHAVIORAL

Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet

Also known as: chart reminder, mailed education, FIT

chart reminder, educational mat'ls, FIT

CR,ed mat'ls, FIT, phone call BEHAVIORAL

Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet. Subjects will also receive a telephone call from project staff to assess barriers to screening and to encourage CRC screening

CR, ed mat'ls, FIT, phone call

Eligibility Criteria

• Age: 52 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients not up-to-date with CRC screening guidelines based on their responses to baseline survey
• patients with a positive personal history of CRC

You may not qualify if:

• patients with personal history of CRC or inflammatory bowel disease
• patients with a family history of hereditary conditions that put them at high risk for CRC (familial adenomatous polyposis or hereditary, nonpolyposis CRC)
• inability to read and comprehend the Informed Consent or written survey
• patients who are up-to-date with CRC screening guidelines based on their response to the baseline survey

Sponsors & Collaborators

• Barcey T. Levy: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Iowa Research Network, University of Iowa

Iowa City, Iowa, 52242-1097, United States

Location

Related Publications (5)

• Levy BT, Xu Y, Daly JM, Ely JW. A randomized controlled trial to improve colon cancer screening in rural family medicine: an Iowa Research Network (IRENE) study. J Am Board Fam Med. 2013 Sep-Oct;26(5):486-97. doi: 10.3122/jabfm.2013.05.130041.

  PMID: 24004700 BACKGROUND

• Daly JM, Xu Y, Levy BT. Patients whose physicians recommend colonoscopy and those who follow through. J Prim Care Community Health. 2013 Apr 1;4(2):83-94. doi: 10.1177/2150131912464887. Epub 2012 Nov 4.

  PMID: 23799714 BACKGROUND

• Levy BT, Daly JM, Xu Y, 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 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055.

  PMID: 22218627 BACKGROUND

• Ely JW, Levy BT, Daly J, Xu Y. Patient Beliefs About Colon Cancer Screening. J Cancer Educ. 2016 Mar;31(1):39-46. doi: 10.1007/s13187-015-0792-5.

  PMID: 25619196 BACKGROUND

• Daly JM, Xu Y, Ely JW, Levy BT. A randomized colorectal cancer screening intervention trial in the Iowa Research Network (IRENE): study recruitment methods and baseline results. J Am Board Fam Med. 2012 Jan-Feb;25(1):63-72. doi: 10.3122/jabfm.2012.01.110054.

  PMID: 22218626 DERIVED

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

Study Officials

• Barcey T Levy, PhD, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, IAFP Chair in Rural Medicine

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 23, 2011
• Study Start: July 1, 2008
• Primary Completion: April 27, 2010
• Study Completion: July 16, 2015
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)