Condition category
Cancer
Date applied
03/06/2020
Date assigned
09/06/2020
Last edited
03/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Colorectal cancer (CRC) is a leading cause of cancer death in the United States. In North Carolina, as in many parts of the United States, CRC screening is substantially underused in vulnerable and marginalized populations. Uninsured, underinsured, and medically underserved populations rely on community health centers for their healthcare and thus patients served by North Carolina’s community health centers are particularly likely to benefit from efforts and resources to improve CRC screening. The United States Preventive Services Task Force recommends several tests to screen for CRC, including annual screening with a fecal immunochemical test (FIT), for patients ages 50-75 years.

Mailed fecal testing programs have shown promise as an effective approach for increasing CRC screening. Although the effectiveness of mailed FIT-based screening programs has been demonstrated within organized health systems, it is unclear whether this approach is effective, feasible, acceptable, and cost-effective in community health centers, which tend to be under-resourced.

This pilot study was designed to assess the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by two community health centers. Patients who have a positive (abnormal) FIT result need a follow-up (diagnostic) colonoscopy to determine the cause of the positive result; thus, this pilot study also includes a patient navigation component to help patients get a follow-up colonoscopy. Therefore, this pilot study also assessed the effectiveness, feasibility, acceptability, and costs of delivering patient navigation from a central location to facilitate follow-up colonoscopy for patients with a positive (abnormal) FIT result.

Who can participate?
Patients at the participating community health centers aged between 50 and 75 years at average risk for colorectal cancer.

What does the study involve?
Eligible participants will be randomly allocated to receive either usual care or mailed fecal immunochemical test (FIT) screening.

For the mailed fecal immunochemical test (FIT) screening, the study team will mail participants an introductory letter advising them that they should expect to receive a FIT kit in the mail. Next, the study team will mail participants a packet that includes a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit consisting of sample collection materials and a pre-paid return envelope. Participants will receive up to two mailed letters reminding them to complete and return the FIT. Participants will receive their FIT results via letter or phone call. For participants with a positive (abnormal) FIT result, a patient navigator will call them to offer support for completing follow-up colonoscopy. Navigation support includes assessment and resolution of barriers to follow-up colonoscopy including, but not necessarily limited to, information/education, finances, language, and transportation.

What are the possible benefits and risks of participating?
A possible benefit from being in this study is a convenient way to complete colon cancer screening. Screening can help find colon cancer early, when it is small, has not spread to other parts of the body, and might be easier to treat. Risks from being in this study are small. The FIT is an approved colon cancer screening test that is similar to or the same as the one already used by the participants’ doctor’s office.

Where is the study run from?
University of North Carolina Lineberger Comprehensive Cancer Center (USA) and two community health centers in North Carolina (USA)

When is the study starting and how long is it expected to run for?
From September 2018 to September 2021

Who is funding the study?
National Cancer Institute (USA)

Who is the main contact?
Dr Teri Malo
teri.malo@unc.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Reuland

ORCID ID

http://orcid.org/0000-0002-7839-6581

Contact details

101 E. Weaver St.
Carrboro
27510
United States of America
+1 (919) 391-7775
daniel_reuland@med.unc.edu

Type

Public

Additional contact

Dr Teri Malo

ORCID ID

http://orcid.org/0000-0002-5620-4841

Contact details

101 E. Weaver St.
Carrboro
27510
United States of America
+1 (919) 445-6217
teri.malo@unc.edu

Type

Public

Additional contact

Ms Alexis Moore

ORCID ID

Contact details

101 E. Weaver St.
Carrboro
27510
United States of America
+1 (919) 962-5409
alexis_moore@unc.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

NCT04406714

Protocol/serial number

Nil known

Study information

Scientific title

Scaling Colorectal cancer screening through Outreach, Referral, and Engagement (SCORE): a state-level program to reduce colorectal cancer burden in vulnerable populations

Acronym

SCORE

Study hypothesis

This pilot study aims to assess the effectiveness, feasibility, acceptability, and cost-effectiveness of mailed fecal immunochemical test (FIT) screening, compared to usual care, among patients of two community health centers who are due for colorectal cancer (CRC) screening

Ethics approval

Approved 25/10/2018, the University of North Carolina at Chapel Hill Office of Human Research Ethics (720 Martin Luther King, Jr. Blvd. Bldg. 385, 2nd Floor CB #7097 Chapel Hill, NC, USA 27599-7097; irb_questions@unc.edu; +1 (919)-966-3113), ref:18-1074

Study design

Randomized controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Screening

Patient information sheet

Condition

Colorectal cancer

Intervention

Patients at two community health centers will be randomly selected and allocated to receive either the intervention or usual care (control).

Intervention: The study team will mail participants an introductory letter advising them that they should expect to receive a fecal immunochemical test (FIT) kit in the mail. Next, the study team will mail participants a packet that includes a cover letter, colorectal cancer (CRC) information sheet, FIT instruction sheet, and FIT kit consisting of sample collection materials and a pre-paid return envelope. Participants will receive up to two mailed letters reminding them to complete and return the FIT. Participants will receive their FIT results via letter or phone call. For participants with a positive (abnormal) FIT result, a patient navigator will call them to offer support for completing follow-up colonoscopy. Navigation support includes assessment and resolution of barriers to follow-up colonoscopy including, but not necessarily limited to, information/education, finances, language, and transportation.

Usual care (control): Patients randomized to this arm will receive usual care. Current usual care at the participating community health centers consists of a visit-based FIT distribution approach.

As part of this pilot study, the study team iteratively tested and refined the protocols for identifying eligible patients who met study inclusion criteria, using an automated query of the electronic health records at each community health center. Because electronic health records are based on best available information and may not reflect screenings performed at another facility, the study materials included a phone number for patients to contact the study team to self-identify as ineligible. Several queries were performed at each community health center throughout the pilot study to identify potentially eligible patients for each study wave. A computerized random number generator was used to randomly select patients for each wave. As part of the initial pilot testing of the mailed FIT intervention, randomly selected patients only were included in the mailed FIT intervention arm. For later waves, participants were randomly selected and assigned 1:1:1 to usual care, mailed FIT intervention, or mailed FIT intervention plus a telephone call reminder. Because so few patients completed a FIT after they were reached by phone, the study team determined that phone calls were unlikely to be a cost-effective method for increasing FIT completion in this context. For the latest study waves, the protocol was to randomly select and assign patients 1:1 to usual care or mailed FIT intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The proportion of individuals who complete colorectal cancer (CRC) screening within 6 months, using any of the screening modalities recommended by the United States Preventive Service Task Force (fecal immunochemical test [FIT], fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography), assessed through electronic health record review at 6 months.

Secondary outcome measures

1. Proportion of participants who return a completed mailed fecal immunochemical test (FIT) at 60 days assessed through electronic health record review at 60 days
2. Feasibility of a mailed FIT outreach program assessed using tracking data captured in a REDCap database to measure the proportion of bad mailing addresses, at 60 days
3. Acceptability of a mailed FIT outreach program assessed using semi-structured interviews with patients up to 24 months after initial FIT mailing
4. Cost-effectiveness of a mailed FIT outreach program assessed through comparison of the programmatic costs incurred and the number of individuals screened in the intervention arm compared to usual care (cost of intervention minus the cost of usual care, divided by the number screened in the intervention arm minus the number screened in usual care) through study completion, up to 36 months after initial FIT mailing

Overall trial start date

20/09/2018

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 50 and 75 years
2. At average risk for colorectal cancer (CRC). Average risk defined as those patients who do not have any of the following: history of CRC, colonic adenomas, Lynch syndrome, family history of CRC, or diagnosis of inflammatory bowel disease.
3. Active patient (seen within the past 18 months) of the community health centers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Record of fecal occult blood test (FOBT)/fecal immunochemical test (FIT) within 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years
2. Record of any colorectal cancer diagnosis or total colectomy

Recruitment start date

20/09/2018

Recruitment end date

31/03/2021

Locations

Countries of recruitment

United States of America

Trial participating centre

University of North Carolina Lineberger Comprehensive Cancer Center
450 West Drive
Chapel Hill
27599
United States of America

Trial participating centre

Roanoke Chowan Community Health Center
120 Health Center Dr
Ahoskie
27910
United States of America

Trial participating centre

Blue Ridge Health
2579 Chimney Rock Rd
Hendersonville
28792
United States of America

Sponsor information

Organisation

UNC Lineberger Comprehensive Cancer Center

Sponsor details

450 West Drive
Chapel Hill
27599
United States of America
+1 (919) 966-3036
ResAdminOSR@unc.edu

Sponsor type

Hospital/treatment centre

Website

https://unclineberger.org/

Funders

Funder type

Government

Funder name

National Cancer Institute

Alternative name(s)

NCI

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
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.

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.

Intention to publish date

30/09/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2020: The participant information sheet has been uploaded. 09/06/2020: Trial’s existence confirmed by the University of North Carolina at Chapel Hill.