Reducing Colorectal Cancer Death Through Mailed Outreach Screening
2 other identifiers
interventional
782
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jan 2017
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedResults Posted
Study results publicly available
December 24, 2018
CompletedDecember 24, 2018
December 1, 2018
5 months
October 21, 2015
June 7, 2018
December 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The Number of Participants Who Completed the Mailed FIT Test Screening Within 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
6 months
Secondary Outcomes (1)
The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study.
6 months
Study Arms (3)
Usual care
NO INTERVENTIONThese 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.
Screening invitation-reminder
ACTIVE COMPARATORParticipants 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).
Mailed-FIT
ACTIVE COMPARATORParticipants 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).
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- The pragmatic trial will include Veterans in southeastern Pennsylvania and Southern New Jersey who, during the funding year
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- University of Pennsylvaniacollaborator
Study Sites (1)
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 32564804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Carter Paulson, MD MSCA
- Organization
- CMC VAMC
Study Officials
- PRINCIPAL INVESTIGATOR
E. Carter Paulson, MD MSCE
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 23, 2015
Study Start
January 1, 2017
Primary Completion
June 12, 2017
Study Completion
December 30, 2017
Last Updated
December 24, 2018
Results First Posted
December 24, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share