Reducing Colorectal Cancer Death Through Mailed Outreach Screening
NCT ID: NCT02584998
Last Updated: 2018-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
782 participants
INTERVENTIONAL
2017-01-01
2017-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
No interventions assigned to this group
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).
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
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).
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.
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
74 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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E. Carter Paulson, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Locations
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Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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01522
Identifier Type: OTHER
Identifier Source: secondary_id
PPO 14-369
Identifier Type: -
Identifier Source: org_study_id