Promoting Colorectal Cancer Screening in Rural Emergency Departments

This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Motivational interview; Behavioral: Standard of care

Detailed Description

The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 191
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Hatcher, RN, PhD; Phone Number: 859-257-5263; Email: jennifer.hatcher@uky.edu

Study Locations

• United States
  • Kentucky
    • Morehead, Kentucky, United States, 40351
      • Recruiting
      • St. Clair Regional Medical Center
      • Contact: Jennifer Hatcher, RN, PhD; Phone Number: 859-257-5263; Email: jennifer.hatcher@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 50+ years of age
2. Rural Appalachian resident
3. No personal history of colorectal cancer
4. No cognitive impairment
5. Ability to speak and understand English

6. Has not had one of the following colorectal cancer screening tests--

   1. Fecal Occult Blood Test within the past year
   2. Flexible sigmoidoscopy within the past five years, or
   3. Colonoscopy within the past ten years

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interview; Subjects will engage in a brief motivational interview to establish an action plan and discuss follow-up interviews a 3 and 6 months post ED visit	Behavioral: Motivational interview; A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
Active Comparator: Standard of Care; Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit	Behavioral: Standard of care; A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in colorectal cancer screening rate	Number of participants that seek out colorectal cancer screening after a motivational interview with a lay health advisor compared to standard of care (being provided a screening brochure)	6 months

Collaborators and Investigators

• Sponsor: University of Kentucky
• Investigators: Principal Investigator: Jennifer Hatcher, RN, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2014
• Primary Completion (Anticipated): May 30, 2018
• Study Completion (Anticipated): May 30, 2018

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Emergencies; Colorectal Neoplasms
• Other Study ID Numbers: MCC-14-0681-P1H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No