ColoRectal Cancer Screening for Southern California Community Health Centers

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified July 2025 by University of California, San Diego
Sponsor
University of California, San Diego
Information Provided by (Responsible Party)
Elena Martinez
Clinicaltrials.gov Identifier
NCT04941300
Other Study ID Numbers:
IRB # 190990
First Submitted
June 17, 2021
First Posted
June 27, 2021
Last Update Posted
August 25, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on August 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Colorectal Cancer
Other: Mailed FIT Outreach

Study Design

Study TypeInterventional
Actual Enrollment55999 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeScreening
Official TitleCRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
Study Start DateJune 7, 2021
Actual Primary Completion DateAugust 30, 2024
Actual Study Completion DateAugust 30, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Mailed FIT Outreach
Primer, FIT Kit, Reminders, Abnormal FIT Follow-up
Other: Mailed FIT Outreach
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.
Usual Care

Outcome Measures

Primary Outcome Measures
  1. 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).
  2. Colonoscopy after abnormal FIT (primary)
    Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
Secondary Outcome Measures
  1. FIT Completion
    Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months
  2. Time to colonoscopy after abnormal FIT
    Median time to colonoscopy completion after abnormal FIT
  3. Follow-up process
    Proportion of patients with abnormal FIT with a) colonoscopy ordered; b) insurance approval completed; c) precolonoscopy visit scheduled; d) precolonoscopy visit completed; e) adequate bowel preparation at time of colonoscopy; f) treatment evaluation referral initiated and first visit completed if CRC found.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Diego
Locations
University of California, San Diego, Moores Cancer Center | La Jolla California, United States, 92093
Investigators
Principal Investigator: Maria Elena Martinez, University of California, San Diego