Clinical trial NCT04406714: Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
Official title: Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer Screening
Colonoscopy
Community Health Centers
Implementation Science
Patient Navigation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: East Carolina University
First posted: 2020-05-28
Enrollment: 4318
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT).

Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
timeFrame: Up to 6 months after randomization
Secondary outcomes:
measure: Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days
timeFrame: Up to 60 days after randomization
measure: Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
timeFrame: Up to 6 months after diagnostic colonoscopy referral date
measure: Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months
timeFrame: Up to 12 months after screening or diagnostic colonoscopy result date
measure: Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment
timeFrame: Up to 12 months after CRC diagnosis
measure: Number of Subjects Who Received Referral for Cancer Treatment
timeFrame: Up to 6 months after cancer diagnosis date
measure: Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach
timeFrame: Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2
measure: Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75)
timeFrame: Through study completion, up to 36 months after randomization
measure: The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
timeFrame: Up to 6 months after randomization
measure: Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days
timeFrame: 60 days after randomization
measure: Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
timeFrame: Up to 6 months after abnormal FIT result date
Other outcomes:
Locations:
city: Ahoskie
country: United States
facility: Roanoke Chowan Community Health Center
state: North Carolina
city: Hendersonville
country: United States
facility: Blue Ridge Health
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Daniel S Reuland, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Siegel RL, Sahar L, Robbins A, Jemal A. Where can colorectal cancer screening interventions have the most impact? Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1151-6. doi: 10.1158/1055-9965.EPI-15-0082. Epub 2015 Jul 8.
citation: US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.
citation: Malo TL, Correa SY, Moore AA, Ferrari RM, Leeman J, Brenner AT, Wheeler SB, Tan X, Reuland DS; Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) Study Protocol Consortium. Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial. Implement Sci Commun. 2021 Oct 7;2(1):113. doi: 10.1186/s43058-021-00194-x.