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

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04406714
• Other study ID #: LCCC2056
• Secondary ID: 4UH3CA233251-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4400
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Trial Mailed FIT Intervention - Age Group 50-75
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
• Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: "Important information from your doctor". Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.
• Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49
Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.

Locations

Country	Name	City	State
United States	Roanoke Chowan Community Health Center	Ahoskie	North Carolina
United States	Blue Ridge Health	Hendersonville	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	East Carolina University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8. — View Citation

Church TR, Yeazel MW, Jones RM, Kochevar LK, Watt GD, Mongin SJ, Cordes JE, Engelhard D. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004 May 19;96(10):770-80. doi: 10.1093/jnci/djh134. — View Citation

Daly JM, Levy BT, Merchant ML, Wilbur J. Mailed fecal-immunochemical test for colon cancer screening. J Community Health. 2010 Jun;35(3):235-9. doi: 10.1007/s10900-010-9227-8. — View Citation

Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294. — View Citation

Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008 Jan-Feb;28(1):56-65. doi: 10.1177/0272989X07309643. — View Citation

Kempe KL, Shetterly SM, France EK, Levin TR. Automated phone and mail population outreach to promote colorectal cancer screening. Am J Manag Care. 2012 Jul;18(7):370-8. — View Citation

Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055. — View Citation

Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, Melillo S, Carvalho M, Taplin S, Bastani R, Rimer BK, Vernon SW, Melvin CL, Taylor V, Fernandez M, Glanz K; Community Preventive Services Task Force. Effectiveness of interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic reviews for the guide to community preventive services. Am J Prev Med. 2012 Jul;43(1):97-118. doi: 10.1016/j.amepre.2012.04.009. — View 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. — View 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. Erratum In: JAMA. 2016 Aug 2;316(5):545. JAMA. 2017 Jun 6;317(21):2239. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants who return a completed mailed FIT at 90 days (exploratory outcome) (Trial Age Group 50-75)	Proportion of participants in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.	90 days after randomization
Other	Number of days from abnormal FIT result date to diagnostic colonoscopy (Trial - Age Group 50-75)	Number of days from abnormal FIT result to the date of completed diagnostic colonoscopy among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of FIT result and diagnostic colonoscopy.	Up to 6 months after abnormal FIT result date
Primary	Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75)	Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.	18 months after randomization
Secondary	Proportion of subjects who return a completed mailed FIT at 60 days (Trial - Age Group 50-75)	Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.	60 days after randomization
Secondary	Proportion of subjects who complete a follow-up (diagnostic) colonoscopy at 6 months (Trial - Age Group 50-75)	Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.	6 months after diagnostic colonoscopy result date
Secondary	Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75)	Number of CRCs and advanced adenomas detected among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete a screening or follow-up (diagnostic) colonoscopy per electronic health record review.	12 months after screening or diagnostic colonoscopy result date
Secondary	Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75)	Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.	Up to 12 months after CRC diagnosis
Secondary	Number of subjects who receive referral for cancer treatment (Trial - Age Group 50-75)	Number of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who receive referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.	6 months after cancer diagnosis date
Secondary	Number of mailed FITs completed after two rounds of annual FIT outreach (Trial - Age Group 50-75)	Number of mailed FITs completed (0, 1, or 2) by subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) after two rounds of annual FIT outreach, per electronic health record review.	Up to 18 months after randomization
Secondary	Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75)	Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.	Through study completion, up to 36 months after randomization
Secondary	Proportion of subjects, ages 45-49, who are current with CRC screening (Sub-study - Age Group 45-49)	The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.	6 months after randomization
Secondary	Proportion of subjects, ages 45-49, who completed mailed FIT at 60 days (Sub-study - Age Group 45-49)	The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who return a completed FIT.	60 days after randomization
Secondary	Proportion of subjects who complete a follow-up diagnostic colonoscopy at 60 days (Sub-study - Age Group 45-49)	Proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review.	60 days after abnormal FIT result date

External Links

•   UNC Lineberger Comprehensive Cancer Center Clinical Trials