Back to resultsOutreach and Choice in Colorectal Cancer Screening
Primary Purpose
Colorectal Cancer Screening
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outreach
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer Screening
Eligibility Criteria
Inclusion Criteria:
- Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).
- The assessment of screening status will happen monthly, on a rolling basis.
Definition of being up to date with CRC screening includes any one of the following:
i) FIT or guaiac-FOBT within 1 year, OR
ii) Colonoscopy within 10 years, OR
iii) Sigmoidoscopy within 5 years, OR
iv) CT colonography within 5 years, OR
v) Cologuard within 3 years
Exclusion Criteria:
- Age outside the 45-75 range.
- History of precancerous polyps requiring colonoscopy surveillance.
- Already being up to date with CRC screening, as defined above.
- Evidence of total removal of the colon which would eliminate the need for screening.
Sites / Locations
- Stanford University Primary Care ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Active choice
Sequential choice
Arm Description
FIT or colonoscopy
FIT offered first, then colonoscopy offered to those still unscreened
Outcomes
Primary Outcome Measures
Number of patients with screening completion
Number of patients with FIT or colonoscopy completed
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04940442
Brief Title
Outreach and Choice in Colorectal Cancer Screening
Official Title
Outreach and Choice in Colorectal Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test [FIT] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active choice
Arm Type
Experimental
Arm Description
FIT or colonoscopy
Arm Title
Sequential choice
Arm Type
Experimental
Arm Description
FIT offered first, then colonoscopy offered to those still unscreened
Intervention Type
Behavioral
Intervention Name(s)
Outreach
Intervention Description
Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened
Primary Outcome Measure Information:
Title
Number of patients with screening completion
Description
Number of patients with FIT or colonoscopy completed
Time Frame
6 months from initial offer
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).
The assessment of screening status will happen monthly, on a rolling basis.
Definition of being up to date with CRC screening includes any one of the following:
i) FIT or guaiac-FOBT within 1 year, OR
ii) Colonoscopy within 10 years, OR
iii) Sigmoidoscopy within 5 years, OR
iv) CT colonography within 5 years, OR
v) Cologuard within 3 years
Exclusion Criteria:
Age outside the 45-75 range.
History of precancerous polyps requiring colonoscopy surveillance.
Already being up to date with CRC screening, as defined above.
Evidence of total removal of the colon which would eliminate the need for screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Ladabaum, MD
Phone
6507252850
Email
uri.ladabaum@stanford.edu
Facility Information:
Facility Name
Stanford University Primary Care Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Ladabaum, MD
Phone
650-725-2850
Email
uri.ladabaum@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outreach and Choice in Colorectal Cancer Screening
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