Reducing Rural Colon Cancer Disparities

NCT ID: NCT03457454

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

431 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-08

Study Completion Date

2021-03-18

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Primary Care Provider/Staff Participants Interview

Intervention Type OTHER

-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.

Patient Participant Interview

Intervention Type OTHER

-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.

Patient Participant Anonymous Survey

Intervention Type OTHER

-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.

Colonoscopy Provider/Staff Participants Interviews

Intervention Type OTHER

-Approximately a 30 minute interview

Interventions

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Primary Care Provider/Staff Participants Interview

-Approximately a 30 minute interview

Intervention Type OTHER

Patient Participant Interview

-Approximately 45-60 minute interview

Intervention Type OTHER

Patient Participant Anonymous Survey

-Survey completion will take approximately 15 minutes

Intervention Type OTHER

Colonoscopy Provider/Staff Participants Interviews

-Approximately a 30 minute interview

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Positive FOBT or colonoscopy


* 50 years of age or older
* Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months

Exclusion Criteria

-None


* Negative FOBT or colonoscopy
* Younger than 50 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimee James, Ph.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Southern Illinois Healthcare

Carbondale, Illinois, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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U01CA209861-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201704046

Identifier Type: -

Identifier Source: org_study_id

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