Reducing Rural Colon Cancer Disparities

NCT03457454 | Completed DMC

• 2 other identifiers: 201704046U01CA209861-01A1
• Study Type: observational
• Target: 431
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (4)

• Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics

  -This will be measured by interviews

  Through completion of study (estimated to be 18 months)

• Assess factors that could influence implementation of multi-level EBIs

  -This will be measured by interviews

  Through completion of study (estimated to be 18 months)

• Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy

  -This will be measured by interviews

  Through completion of study (estimated to be 18 months)

• Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners

  -This will be measured by interviews

  Through completion of study (estimated to be 18 months)

Study Arms (4)

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

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

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

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

Interventions

Primary Care Provider/Staff Participants Interview OTHER

-Approximately a 30 minute interview

Primary Care Provider/Staff Participants Interviews

Patient Participant Interview OTHER

-Approximately 45-60 minute interview

Patient Participants Interviews

Patient Participant Anonymous Survey OTHER

-Survey completion will take approximately 15 minutes

Patient Participants Anonymous Survey

Colonoscopy Provider/Staff Participants Interviews OTHER

-Approximately a 30 minute interview

Colonoscopy Provider/Staff Participants Interviews

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None
• Negative FOBT or colonoscopy
• Younger than 50 years of age

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Southern Illinois Healthcare

Carbondale, Illinois, 62901, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Physicians, Primary Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Aimee James, Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: September 8, 2017
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)