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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457454
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (FOBT) in rural patients.

Condition or disease Intervention/treatment
Colon Cancer Other: Primary Care Provider/Staff Participants Interview Other: Patient Participant Interview Other: Patient Participant Anonymous Survey Other: Colonoscopy Provider/Staff Participants Interviews

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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
  • Up to two primary care providers and at least one staff person at each of the 16 clinics, with approximately 5 interviewees per clinic. 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.
  • If the participant verbally consents, the research team member will conduct an interview with the provider to learn about the current processes used to support and monitor colorectal cancer screening (CRC) from screening initiation through follow-up; assess capacity and interest in implementing Evidence Based Practices for supporting and monitoring CRC screening, including any ideas interviewees have or find appealing; and engage the organizations as partners to build interest, capacity, and infrastructure for future intervention trial and other future studies.
Other: Primary Care Provider/Staff Participants Interview
-Approximately a 30 minute interview

Patient Participants Interviews
  • 10 patients across 5 clinics will be recruited for interviews, which will address the patient experience with screening and follow-up.
  • If the participant verbally consents, the research team member will conduct an interview with the patient participant to gain a deeper understanding of the CRC screening process from the patient's perspective; the gaps, challenges, or road blocks/speed bumps to completing CRC screening steps; and what organizations can do better or differently to help people complete the CRC screening process.
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.
Other: Patient Participant Anonymous Survey
-Survey completion will take approximately 15 minutes

Colonoscopy Provider/Staff Participants Interviews
  • Colonoscopy providers and a staff or mid-level provider in each office will be recruited for interviews.
  • If the participant consents, the research team member will conduct an interview to learn about current processes used to support and monitor colorectal cancer screening from the perspective of gastroenterology/colonoscopy sites and to learn about how gastroenterology/colonoscopy sites communicate and coordinate care with other healthcare organizations and patients to support and monitor colorectal cancer screening.
Other: Colonoscopy Provider/Staff Participants Interviews
-Approximately a 30 minute interview




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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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
Study Population
Primary Care Providers/Staff Participants, Patient Participants, and Colonoscopy Provider/Staff Participants from Southern Illinois Healthcare.
Criteria

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


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


Locations
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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
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
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: April 1, 2021
Last Verified: March 2021
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