ColoRectal Cancer Screening for Southern California Community Health Centers
Primary Purpose
Colorectal Cancer
Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mailed FIT Outreach
Standardized navigation
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring screening, underserved populations
Eligibility Criteria
Mailed FIT Inclusion Criteria:
- Patient had an office visit within the last 12 months at one or more of your health centers. (Use Uniform Data System [UDS] criteria for an office visit.)
- Not up to date with colorectal cancer screening according to the standard UDS query
- Male or Female
- 50 - 75 years old
- Current VALID address in San Diego or Riverside Counties (addresses with a PO box or General Delivery are acceptable)
- Valid Phone Number
- Insured patients only (e.g., Medicare, Medi-Cal, or private insurance)
Exclusion Criteria:
- Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
- Absence of a valid mailing address (e.g. blank field)
- Uninsured
- Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
- Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)
Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:
- Completion of a FIT for Colorectal Cancer Screening during the designated time period
- Abnormal FIT result received and documented in EMR during the designated time period
Sites / Locations
- University of California, San Diego, Moores Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Mailed FIT Outreach
Usual Care
Arm Description
Primer, FIT Kit, Reminders, Abnormal FIT Follow-up
Outcomes
Primary Outcome Measures
Screening up-to-date (primary)
Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
Colonoscopy after abnormal FIT (Primary)
Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
Secondary Outcome Measures
FIT Completion
Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months
Full Information
NCT ID
NCT04941300
First Posted
June 18, 2021
Last Updated
July 5, 2023
Sponsor
University of California, San Diego
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04941300
Brief Title
ColoRectal Cancer Screening for Southern California Community Health Centers
Official Title
CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening, underserved populations
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mailed FIT Outreach
Arm Type
Other
Arm Description
Primer, FIT Kit, Reminders, Abnormal FIT Follow-up
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Mailed FIT Outreach
Intervention Description
We will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return.
Intervention Type
Other
Intervention Name(s)
Standardized navigation
Intervention Description
The standardized navigation includes, but is not limited to, the following key components:
Identification of individuals with abnormal FIT
Results review and colonoscopy order by provider
Results reporting to patient
Insurance approval for colonoscopy
Colonoscopy scheduling
Bowel preparation & colonoscopy completion
Colonoscopy results provided to patient and CHC
Referral-to-Care for patients with CRC (if necessary)
Primary Outcome Measure Information:
Title
Screening up-to-date (primary)
Description
Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
Time Frame
Twelve months
Title
Colonoscopy after abnormal FIT (Primary)
Description
Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
Time Frame
Six months
Secondary Outcome Measure Information:
Title
FIT Completion
Description
Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months
Time Frame
Twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mailed FIT Inclusion Criteria:
Patient had an office visit within the last 12 months at one or more of your health centers. (Use Uniform Data System [UDS] criteria for an office visit.)
Not up to date with colorectal cancer screening according to the standard UDS query
Male or Female
50 - 75 years old
Current VALID address in San Diego or Riverside Counties (addresses with a PO box or General Delivery are acceptable)
Valid Phone Number
Insured patients only (e.g., Medicare, Medi-Cal, or private insurance)
Exclusion Criteria:
Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
Absence of a valid mailing address (e.g. blank field)
Uninsured
Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)
Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:
Completion of a FIT for Colorectal Cancer Screening during the designated time period
Abnormal FIT result received and documented in EMR during the designated time period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Martinez
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ColoRectal Cancer Screening for Southern California Community Health Centers
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