Reducing Rural Colon Cancer Disparities

Colon Cancer Clinical Trial

Official title:

Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457454
• Other study ID #: 201704046
• Secondary ID: U01CA209861-01A1
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: March 18, 2021

Study information

• Verified date: March 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• Primary Care Provider/Staff Participants Interview
-Approximately a 30 minute interview
• Patient Participant Interview
-Approximately 45-60 minute interview
• Patient Participant Anonymous Survey
-Survey completion will take approximately 15 minutes
• Colonoscopy Provider/Staff Participants Interviews
-Approximately a 30 minute interview

Locations

Country	Name	City	State
United States	Southern Illinois Healthcare	Carbondale	Illinois
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

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