ColoRectal Cancer Screening for Southern California Community Health Centers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico

NCT05661292

Colorectal Cancer Screening

UNKNOWN

Systems Intervention to Promote Colorectal Cancer (CRC) Screening

NCT01299493

Carcinoma

COMPLETED NA

Study to Increase Colorectal Screening

NCT02870049

Colorectal Cancer

COMPLETED NA

Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

NCT01742169

Colorectal Neoplasms

COMPLETED NA

Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

NCT05064410

Colorectal Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mailed FIT Outreach

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

Group Type OTHER

Mailed FIT Outreach

Intervention Type 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.

Standardized navigation

Intervention Type 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)

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Standardized navigation

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

* 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

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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No