ColoRectal Cancer Screening for Southern California Community Health Centers

NCT04941300 | Completed Phase 3

• 2 other identifiers: IRB # 1909905UH3CA233314-05
• Study Type: interventional
• Target: 55,999
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

screening; underserved populations

Outcome Measures

Primary Outcomes (2)

• 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).

  Three years

• Colonoscopy after abnormal FIT (primary)

  Proportion of patients with abnormal FIT who complete colonoscopy within 6 months

  Six months

Secondary Outcomes (3)

• FIT Completion

  Twelve months

• Time to colonoscopy after abnormal FIT

  From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years

• Follow-up process

  From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years

Other Outcomes (1)

• Repeat screening (exploratory outcome)

  12-14 months

Study Arms (2)

Mailed FIT Outreach

OTHER

Primer, FIT Kit, Reminders, Abnormal FIT Follow-up

Other: Mailed FIT Outreach; Other: Standardized navigation

Usual Care

NO INTERVENTION

Interventions

Mailed FIT Outreach OTHER

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.

Mailed FIT Outreach

Standardized navigation OTHER

The standardized navigation includes, but is not limited to, the following key components: 1. Identification of individuals with abnormal FIT 2. Results review and colonoscopy order by provider 3. Results reporting to patient 4. Insurance approval for colonoscopy 5. Colonoscopy scheduling 6. Bowel preparation \& colonoscopy completion 7. Colonoscopy results provided to patient and CHC 8. Referral-to-Care for patients with CRC (if necessary)

Mailed FIT Outreach

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Diego, Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Castaneda SF, Gupta S, Nodora JN, Largaespada V, Roesch SC, Rabin BA, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Halpern MT, Martinez ME. Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol. Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5.

  PMID: 37802222 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Maria Elena Martinez

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: June 8, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)