Promoting Colorectal Cancer Screening in Rural Emergency Departments
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interview
Standard of care
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 50+ years of age
- Rural Appalachian resident
- No personal history of colorectal cancer
- No cognitive impairment
- Ability to speak and understand English
Has not had one of the following colorectal cancer screening tests--
- Fecal Occult Blood Test within the past year
- Flexible sigmoidoscopy within the past five years, or
- Colonoscopy within the past ten years
Exclusion Criteria:
-
Sites / Locations
- St. Clair Regional Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interview
Standard of Care
Arm Description
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
Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03473587
First Posted
January 18, 2018
Last Updated
March 14, 2018
Sponsor
University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT03473587
Brief Title
Promoting Colorectal Cancer Screening in Rural Emergency Departments
Official Title
Promoting Colorectal Cancer Screening in Rural Emergency Departments
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2014 (Actual)
Primary Completion Date
May 30, 2018 (Anticipated)
Study Completion Date
May 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
191 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interview
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit
Intervention Type
Behavioral
Intervention Name(s)
Motivational interview
Intervention Description
A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening
Primary Outcome Measure Information:
Title
Change in colorectal cancer screening rate
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
50+ years of age
Rural Appalachian resident
No personal history of colorectal cancer
No cognitive impairment
Ability to speak and understand English
Has not had one of the following colorectal cancer screening tests--
Fecal Occult Blood Test within the past year
Flexible sigmoidoscopy within the past five years, or
Colonoscopy within the past ten years
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Hatcher, RN, PhD
Phone
859-257-5263
Email
jennifer.hatcher@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Hatcher, RN, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Clair Regional Medical Center
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hatcher, RN, PhD
Phone
859-257-5263
Email
jennifer.hatcher@uky.edu
12. IPD Sharing Statement
Learn more about this trial
Promoting Colorectal Cancer Screening in Rural Emergency Departments
We'll reach out to this number within 24 hrs