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Reducing Rural Colon Cancer Disparities

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457454
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The proposed research fills a significant gap in rigorous intervention studies to eliminate rural-urban disparities in cancer outcomes. The persistent poverty and health disparities in Southern Illinois is a prime example of rural cancer health disparities. The investigators' approach to developing and testing the multi-level intervention will serve as a model for working in other rural areas.

Condition or disease Intervention/treatment Phase
Colon Cancer Other: Informational Intervention Other: Colonoscopy scheduling assistance Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1816 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Participant Level Education
-Participants receive low-literacy educational and instructional brochures at the time of fecal occult blood test (FOBT) referral. Participants with a positive FOBT receive a second low-literacy brochure on bowel preparation for colonoscopy and the importance of follow-up, and assist with scheduling and completing colonoscopy
 Other: Informational Intervention
Receive low-literacy educational and instructional brochures

Other: Colonoscopy scheduling assistance
-Clinics will receive prompts to engage participants to schedule a colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Report of results of positive FOBT to the referring provider [ Time Frame: Completion of study (estimated to be 41 months) ]
    -Percentage of FOBTs with results documented

  2. Report of results of positive FOBT to the patient [ Time Frame: Completion of study (estimated to be 41 months) ]
    -Percentage of patients with colonoscopy referral after positive FOBT

  3. Initiation of colonoscopy after positive FOBT [ Time Frame: Completion of study (estimated to be 41 months) ]
    -Percentage of patients that schedule a colonoscopy after positive FOBT

  4. Completion of colonoscopy after positive FOBT [ Time Frame: Completion of study (estimated to be 41 months) ]
    -Percentage of patients that complete colonoscopy after positive FOBT


Secondary Outcome Measures :
  1. Documentation of screening/surveillance interval after colonoscopy as measured by percentage of patients that complete colonoscopy that have documentation of next screening date [ Time Frame: Completion of study (estimated to be 41 months) ]
  2. Time to colonoscopy after positive FOBT [ Time Frame: Completion of study (estimated to be 41 months) ]
    -Median number of days from abnormal FOBT to completion of colonoscopy


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 50-75
  • Positive FOBT during the study period

Exclusion Criteria:

-No medical contra-indication for colonoscopy

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03457454


Contacts
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Contact: Aimee James, Ph.D., MPH 314-454-8300 aimeejames@wustl.edu

Locations
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United States, Illinois
Southern Illinois Healthcare Recruiting
Carbondale, Illinois, United States, 62901
Contact: Marci Moore-Connelley, M.D.    618-536-6621    seniormanagement@sih.net   
Principal Investigator: Marci Moore-Connelley, M.D.         
Sub-Investigator: Kevin Oestmann, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aimee James, Ph.D., MPH    314-454-8300    aimeejames@wustl.edu   
Principal Investigator: Aimee James, Ph.D., MPH         
Sub-Investigator: Graham Colditz, M.D., DrPH         
Sub-Investigator: Jean Wang, M.D., Ph.D.         
Sub-Investigator: Jean Hunleth, MPH, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aimee James, Ph.D., MPH Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03457454    
Other Study ID Numbers: 201704046
U01CA209861-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases