Reducing Rural Colon Cancer Disparities
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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. |
ClinicalTrials.gov Identifier: NCT03457454 |
Recruitment Status :
Completed
First Posted : March 7, 2018
Last Update Posted : April 1, 2021
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Condition or disease | Intervention/treatment |
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Colon Cancer | Other: Primary Care Provider/Staff Participants Interview Other: Patient Participant Interview Other: Patient Participant Anonymous Survey Other: Colonoscopy Provider/Staff Participants Interviews |
Study Type : | Observational |
Actual Enrollment : | 431 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Actual Primary Completion Date : | March 18, 2021 |
Actual Study Completion Date : | March 18, 2021 |
Group/Cohort | Intervention/treatment |
---|---|
Primary Care Provider/Staff Participants Interviews
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Other: Primary Care Provider/Staff Participants Interview
-Approximately a 30 minute interview |
Patient Participants Interviews
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Other: Patient Participant Interview
-Approximately 45-60 minute interview |
Patient Participants Anonymous Survey
-Patient participants will be recruited to take an anonymous mailed survey, which will address patient level barriers to screening and follow-up focusing on out of pocket costs.
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Other: Patient Participant Anonymous Survey
-Survey completion will take approximately 15 minutes |
Colonoscopy Provider/Staff Participants Interviews
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Other: Colonoscopy Provider/Staff Participants Interviews
-Approximately a 30 minute interview |
- Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics [ Time Frame: Through completion of study (estimated to be 18 months) ]-This will be measured by interviews
- Assess factors that could influence implementation of multi-level EBIs [ Time Frame: Through completion of study (estimated to be 18 months) ]-This will be measured by interviews
- Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy [ Time Frame: Through completion of study (estimated to be 18 months) ]-This will be measured by interviews
- Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners [ Time Frame: Through completion of study (estimated to be 18 months) ]-This will be measured by interviews

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria for Primary Care Provider/Staff Participants -Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process.
Inclusion Criteria for Patient Participants (Interview)
-Positive FOBT or colonoscopy
Inclusion Criteria for Patient Participants (Survey)
- 50 years of age or older
- Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months
Inclusion Criteria for Colonoscopy Provider/Staff Participants -Provider and a staff or mid-level provider in each office (5 colonoscopy providers in the Southern Illinois Healthcare region)
Exclusion Criteria for Primary Care Provider/Staff Participants
-None
Exclusion Criteria for Patient Participants (Interview)
- Negative FOBT or colonoscopy
- Exclusion Criteria for Patient Participants (Survey)
- Younger than 50 years of age
Exclusion Criteria for Colonoscopy Provider/Staff Participants None

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
United States, Illinois | |
Southern Illinois Healthcare | |
Carbondale, Illinois, United States, 62901 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Aimee James, Ph.D., MPH | Washington University School of Medicine |
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: | April 1, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |