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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03473587
Other study ID # MCC-14-0681-P1H
Secondary ID
Status Recruiting
Phase N/A
First received January 18, 2018
Last updated March 14, 2018
Start date November 7, 2014
Est. completion date May 30, 2018

Study information

Verified date March 2018
Source University of Kentucky
Contact Jennifer Hatcher, RN, PhD
Phone 859-257-5263
Email jennifer.hatcher@uky.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 191
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interview
A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
Standard of care
A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

Locations

Country Name City State
United States St. Clair Regional Medical Center Morehead Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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