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Promoting Colorectal Cancer Screening in Rural Emergency Departments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03473587
Recruitment Status : Unknown
Verified March 2018 by Jennifer Hatcher, University of Kentucky.
Recruitment status was:  Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Jennifer Hatcher, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Motivational interview Behavioral: Standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Promoting Colorectal Cancer Screening in Rural Emergency Departments
Actual Study Start Date : November 7, 2014
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

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

Primary Outcome Measures :
  1. Change in colorectal cancer screening rate [ Time Frame: 6 months ]
    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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03473587

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Contact: Jennifer Hatcher, RN, PhD 859-257-5263

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United States, Kentucky
St. Clair Regional Medical Center Recruiting
Morehead, Kentucky, United States, 40351
Contact: Jennifer Hatcher, RN, PhD    859-257-5263   
Sponsors and Collaborators
University of Kentucky
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Principal Investigator: Jennifer Hatcher, RN, PhD University of Kentucky

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Responsible Party: Jennifer Hatcher, Principal Investigator, University of Kentucky Identifier: NCT03473587    
Other Study ID Numbers: MCC-14-0681-P1H
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes