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NCT04941300CompletedPhase 3

ColoRectal Cancer Screening for Southern California Community Health Centers

CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers

Source: ClinicalTrials.gov · Last updated 26 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
55999 (actual)
First submitted
18 Jun 2021
Start date
8 Jun 2021
Primary completion date
31 Aug 2024
Lead sponsor
University of California, San Diego
NCT number
NCT04941300

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 55999
  • From 8 Jun 2021 to the primary completion date, 31 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Abnormal FIT result received and documented in EMR during the designated time period

Other illness

  • Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
  • Completion of a FIT for Colorectal Cancer Screening during the designated time period

Other

  • 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
  • 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:

Criteria the registry did not label

  • 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)

Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Diego Moores Cancer Center
Coordinator of this site? Confirm its status		La JollaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.