Reducing Rural Colon Cancer Disparities

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Aimee James, Ph.D., MPH; Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and 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
• 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

Additional relevant MeSH terms:

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