Clinical trial NCT04651504: Rural Colon Cancer Screening Toolkit Intervention
Official title: Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer Screening
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-12-03
Enrollment: 83663
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This is a stepped wedge trial where clusters of sites sequentially enter the intervention. Independent samples of patients are enrolled within a cluster at each set interval of time thus, it is analyzed as a repeated cross-sectional study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.


Eligibility criteria: Inclusion Criteria for Primary Care Clinic Sites

* Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare

Exclusion Criteria for Primary Care Clinic Sites

* Not a part of the PHO

Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

* Employment at the relevant clinic at the time of the study

Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

* Not employed at the relevant clinic at the time of the study

Inclusion Criteria for Patients

* Age 45-75 during the study period
* Must be patient of the selected primary care clinic sites

Exclusion Criteria for Patients

* Younger than 45 years of age or older than 75 years of age during the study period
* Not a patient of the selected primary care clinic sites

Inclusion Criteria for Community Members

* Age 45-75 at the time of the health fair or screening event
* Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Exclusion Criteria for Community Members

* Younger than 45 years of age or older than 75 years of age
* Unable to undergo stool testing

Primary outcomes:
measure: Number of referrals for colonoscopies after positive fecal immunochemical test
timeFrame: Completion of follow-up (estimated to be 44 months)
measure: Number of colonoscopy completions after positive fecal immunochemical test
timeFrame: Completion of follow-up (estimated to be 44 months)
Secondary outcomes:
measure: Time to colonoscopy
timeFrame: Completion of follow-up (estimated to be 44 months)
measure: Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test
timeFrame: Completion of follow-up (estimated to be 44 months)
measure: Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test
timeFrame: Completion of follow-up (estimated to be 44 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Aimee James, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: