ColoRectal Cancer Screening for Southern California Community Health Centers

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04941300
• Other study ID #: IRB # 190990
• Secondary ID: 4UH3CA233314-02
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 8, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45000
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Standardized navigation
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)

Locations

Country	Name	City	State
United States	University of California, San Diego, Moores Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeat screening (exploratory outcome)	Proportion of patients who complete one normal FIT with repeat FIT within12-14 months.	12-14 months
Primary	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
Primary	Colonoscopy after abnormal FIT (primary)	Proportion of patients with abnormal FIT who complete colonoscopy within 6 months	Six months
Secondary	FIT Completion	Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months	Twelve months
Secondary	Time to colonoscopy after abnormal FIT	Median time to colonoscopy completion after abnormal FIT	From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years
Secondary	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.	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