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

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trial Mailed FIT Intervention - Age Group 50-75

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

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

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Cancer Screening, Colonoscopy, Community Health Centers, Implementation Science, Patient Navigation

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Roanoke Chowan Community Health Center
Blue Ridge Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Active Comparator

Arm Label

Trial Mailed FIT Intervention - Age Group 50-75

Trial Usual Care - Age Group 50-75

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

Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04406714

First Posted

May 22, 2020

Last Updated

August 31, 2023

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI), East Carolina University

1. Study Identification

Unique Protocol Identification Number

NCT04406714

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI), East Carolina University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Cancer Screening, Colonoscopy, Community Health Centers, Implementation Science, Patient Navigation

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

4400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trial Mailed FIT Intervention - Age Group 50-75

Arm Type

Experimental

Arm Description

Arm Title

Trial Usual Care - Age Group 50-75

Arm Type

No Intervention

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Trial Mailed FIT Intervention - Age Group 50-75

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75)

Description

Time Frame

6 months after randomization

Secondary Outcome Measure Information:

Title

Proportion of subjects who return a completed mailed FIT at 60 days (Trial - Age Group 50-75)

Description

Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.

Time Frame

60 days after randomization

Title

Proportion of subjects who complete a follow-up (diagnostic) colonoscopy at 6 months (Trial - Age Group 50-75)

Description

Time Frame

6 months after diagnostic colonoscopy result date

Title

Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75)

Description

Time Frame

12 months after screening or diagnostic colonoscopy result date

Title

Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75)

Description

Time Frame

Up to 12 months after CRC diagnosis

Title

Number of subjects who receive referral for cancer treatment (Trial - Age Group 50-75)

Description

Time Frame

6 months after cancer diagnosis date

Title

Number of mailed FITs completed after two rounds of annual FIT outreach (Trial - Age Group 50-75)

Description

Time Frame

Up to 18 months after randomization

Title

Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75)

Description

Time Frame

Through study completion, up to 36 months after randomization

Title

Proportion of subjects, ages 45-49, who are current with CRC screening (Sub-study - Age Group 45-49)

Description

Time Frame

6 months after randomization

Title

Proportion of subjects, ages 45-49, who completed mailed FIT at 60 days (Sub-study - Age Group 45-49)

Description

Time Frame

60 days after randomization

Title

Proportion of subjects who complete a follow-up diagnostic colonoscopy at 60 days (Sub-study - Age Group 45-49)

Description

Time Frame

60 days after abnormal FIT result date

Other Pre-specified Outcome Measures:

Title

Proportion of participants who return a completed mailed FIT at 90 days (exploratory outcome) (Trial Age Group 50-75)

Description

Proportion of participants in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review.

Time Frame

90 days after randomization

Title

Number of days from abnormal FIT result date to diagnostic colonoscopy (Trial - Age Group 50-75)

Description

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.

Time Frame

Up to 6 months after abnormal FIT result date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel S Reuland, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roanoke Chowan Community Health Center

City

Ahoskie

State/Province

North Carolina

ZIP/Postal Code

27910

Country

United States

Facility Name

Blue Ridge Health

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28792

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Cancer Moonshot Notice of Award.

IPD Sharing Time Frame

The IPD sharing time frame has not been defined at this time.

IPD Sharing Access Criteria

There are 2 classes of dataset requests: public use and special. Requests are submitted via the IMS website. Requestors electronically sign and submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use dataset containing common data elements is made available to external researchers by application. IMS responds to public use dataset applications by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive administrative review by NCI and RTI before being sent to the SC for review and approval. Requestors report every 6 months and published articles or conference presentations to RTI. Requestors are encouraged to make articles available through PubMed Central.

Citations:

PubMed Identifier

24196665

Citation

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.

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Links:

URL

https://unclineberger.org/patientcare/clinical-trials/

Description

UNC Lineberger Comprehensive Cancer Center Clinical Trials

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

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