Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49; Behavioral: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49; Behavioral: Trial Mailed FIT Intervention - Age Group 50-75

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04406714

4UH3CA233251-02 (U.S. NIH Grant/Contract)

LCCC2056

Details and patient eligibility

About

This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are implementing this study in two age groups, 45-49 years and 50-75 years.

Full description

Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQHCs. Subjects are randomly selected and assigned to receive either a mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services Task Force recommendations for annual screening, we will mail subjects one round of FIT per year for up to two years.

Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a central location to patients who are 45-49 years of age and newly eligible for CRC screening. The sub-study also assesses the impact of varying the appearance of the FIT packet mailing envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm 3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49).

The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness of delivering patient navigation from a central location to facilitate follow up colonoscopy for patients with a positive (abnormal) FIT result.

Enrollment: 4,318 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 45-75 years
• At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative [father, mother, sister, brother], or diagnosis of inflammatory bowel disease)
• No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
• No record of any CRC diagnosis or total colectomy
• No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
• Has a complete North Carolina mailing address in the EHR
• Active patient of the clinic (seen within the past 18 months) at the time of randomization
• No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only)

Exclusion criteria

• Age younger than 45 years or older than 75 years
• Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative [father, mother, sister, brother], or diagnosis of inflammatory bowel disease)
• Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date
• Record of any CRC diagnosis or total colectomy
• Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
• Does not have a complete North Carolina mailing address in the EHR
• Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization
• Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4,318 participants in 4 patient groups

Trial Mailed FIT Intervention - Age Group 50-75

Experimental group

Description:

Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.

Treatment:

Behavioral: Trial Mailed FIT Intervention - Age Group 50-75

Trial Usual Care - Age Group 50-75

No Intervention group

Description:

Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.

Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49

Experimental group

Description:

Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.

Treatment:

Behavioral: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49

Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49

Active Comparator group

Description:

Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.

Treatment:

Behavioral: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49