NCT03473587

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
191

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.6 years

First QC Date

January 18, 2018

Last Update Submit

March 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Motivational Interview

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit

Behavioral: Standard of care

Interventions

A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening

Motivational Interview

A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

Standard of Care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Clair Regional Medical Center

Morehead, Kentucky, 40351, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Motivational InterviewingStandard of Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jennifer Hatcher, RN, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Hatcher, RN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2018

First Posted

March 22, 2018

Study Start

November 7, 2014

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations