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Rural Colon Cancer Screening Toolkit Intervention

Primary Purpose

Colon Cancer Screening

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colorectal Cancer Toolkit
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colon Cancer Screening

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Care Clinics

Arm Description

Southern Illinois Healthcare System will contact the site management and ask for participation in the study Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.

Outcomes

Primary Outcome Measures

Number of referrals for colonoscopies after positive fecal immunochemical test
Number of colonoscopy completions after positive fecal immunochemical test
-Within 60 days of referral

Secondary Outcome Measures

Time to colonoscopy
Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test
Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test

Full Information

First Posted
November 25, 2020
Last Updated
July 5, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04651504
Brief Title
Rural Colon Cancer Screening Toolkit Intervention
Official Title
Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
83573 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Clinics
Arm Type
Experimental
Arm Description
Southern Illinois Healthcare System will contact the site management and ask for participation in the study Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
Intervention Type
Other
Intervention Name(s)
Colorectal Cancer Toolkit
Intervention Description
The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.
Primary Outcome Measure Information:
Title
Number of referrals for colonoscopies after positive fecal immunochemical test
Time Frame
Completion of follow-up (estimated to be 44 months)
Title
Number of colonoscopy completions after positive fecal immunochemical test
Description
-Within 60 days of referral
Time Frame
Completion of follow-up (estimated to be 44 months)
Secondary Outcome Measure Information:
Title
Time to colonoscopy
Time Frame
Completion of follow-up (estimated to be 44 months)
Title
Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test
Time Frame
Completion of follow-up (estimated to be 44 months)
Title
Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test
Time Frame
Completion of follow-up (estimated to be 44 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee James, Ph.D., MPH
Phone
314-454-8300
Email
aimeejames@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee James, Ph.D., MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee James, Ph.D., MPH
Phone
314-454-8300
Email
aimeejames@wustl.edu
First Name & Middle Initial & Last Name & Degree
Aimee James, Ph.D., MPH
First Name & Middle Initial & Last Name & Degree
Graham Colditz, M.D., DrPH
First Name & Middle Initial & Last Name & Degree
Jean Hunleth, Ph.D., MPH
First Name & Middle Initial & Last Name & Degree
Michelle Silver, Ph.D.
First Name & Middle Initial & Last Name & Degree
Esther Lu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Rural Colon Cancer Screening Toolkit Intervention

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