Reducing Colorectal Cancer Death Through Mailed Outreach Screening

• ClinicalTrials.gov Identifier: NCT02584998
• Recruitment Status: Completed
• First Posted: October 23, 2015
• Results First Posted: December 24, 2018
• Last Update Posted: December 24, 2018
• Sponsor: VA Office of Research and Development
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

The main study aim is to develop, implement and disseminate a pilot population-based mailed FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic randomized trial to (1) Compare the effects of usual care (UC), screening invitation + reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity; and (3) Explore barriers to use of mailed outreach screening for Veterans.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Other: Mailed-FIT; Other: Screening invitation-reminder	Not Applicable

Detailed Description:

This study seeks to establish the foundation to systematically study and improve the delivery and effectiveness of colorectal cancer (CRC) screening in the VA by developing, implementing and disseminating a pilot mailed-FIT screening outreach program that does not rely on having a clinical office visit. The investigators specifically address the need to identify and remediate potential failures to identify and offer screening to eligible Veterans through multilevel interventions. The investigators will also create electronic data linkages to, in future studies, enable evaluation of FIT performance characteristics and help close critical evidence gaps for optimizing screening among Veterans. As this is a pilot study, the focus is to assess feasibility of a population-based screening outreach approach through the development, implementation and dissemination of a mailed FIT outreach program in the Philadelphia VA Medical Center that does not rely on having an office visit.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 782 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Reducing Colorectal Cancer Death Through Mailed Outreach Screening
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: June 12, 2017
• Actual Study Completion Date: December 30, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual care; These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
Active Comparator: Screening invitation-reminder; Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).	Other: Screening invitation-reminder; These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm
Active Comparator: Mailed-FIT; Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (plus a screening invitation) followed by the kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update their contact information. They will be informed that a telephone reminder will follow 4 weeks from notification letter if screening is not completed. Participants who do not return their kit within 4 weeks after their pre-notification letter was mailed will receive a live telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).	Other: Mailed-FIT; The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is 100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies.; Other Name: Fecal Immunochemical Test

Outcome Measures

Primary Outcome Measures :

1. The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months [ Time Frame: 6 months ]
   The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test

Secondary Outcome Measures :

1. The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study. [ Time Frame: 6 months ]
   The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• The pragmatic trial will include Veterans in southeastern Pennsylvania and Southern New Jersey who, during the funding year
• 50 to 75 years old
• Have received care at the Philadelphia VA Medical Center in the 18-48 months prior to selection for the study but who have not been seen by primary care in the past 18 months prior to selection
• Due for screening
• Are asymptomatic for CRC
• This includes the period during which 3-sample testing was being regularly used at the Philadelphia VA Medical Center

Exclusion Criteria:

• Have any known gastrointestinal symptoms such as:

  • bleeding
  • unexplained weight loss
  • change in bowel habits
  • family history of CRC
  • inflammatory bowel disease (IBD)
  • colectomy using International Classification of Disease (9th and 10th edition) diagnostic code or by self-report.

• The investigators will also exclude Veterans:

  • with evidence of prior colonoscopy within 10 years
  • sigmoidoscopy within 5 years
  • fecal occult blood test (FOBT)/FIT in the same calendar year
• The information used to exclude patients will be derived from the electronic queries or chart audits.

Contacts and Locations

Locations

United States, Pennsylvania

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VA Office of Research and Development

University of Pennsylvania

Investigators

• Principal Investigator: E. Carter Paulson, MD MSCE; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] December 22, 2015

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldshore MA, Mehta SJ, Fletcher W, Tzanis G, Doubeni CA, Paulson EC. An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care. Am J Prev Med. 2020 Jul;59(1):41-48. doi: 10.1016/j.amepre.2020.02.014.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02584998
• Other Study ID Numbers: PPO 14-369; 01522 ( Other Identifier: Corporal Michael J. Crescenz VA Medical Center )
• First Posted: October 23, 2015
• Results First Posted: December 24, 2018
• Last Update Posted: December 24, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases