search
Back to results

Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FIT Outreach
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Neoplasms

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic men and women
  • 50 to 75 years of age

Exclusion Criteria:

  • Personal history of polyps requiring colonoscopic surveillance
  • Homeless
  • Severe co-morbidities limiting life expectancy e.g., advanced stage cancer

Sites / Locations

  • University of California, San Francisco-San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

FIT Outreach + Usual Care

Arm Description

Patients in this study arm will receive usual care from their primary care clinic.

Patients in this study arm will receive usual care at their primary care clinic and the intervention.

Outcomes

Primary Outcome Measures

Completion of FIT- one year
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.

Secondary Outcome Measures

Incomplete FIT- 28 days
Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
FIT Positive
Among the patients that have completed the FIT the percentage that had a positive FIT test.
Completed Colonoscopy
Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
Colonoscopy Findings
Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
Cost
How much the program costed to start and the costs throughout program implementation.

Full Information

First Posted
November 20, 2015
Last Updated
August 8, 2019
Sponsor
University of California, San Francisco
Collaborators
Stanford University, San Francisco Department of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT02613260
Brief Title
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
Official Title
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Stanford University, San Francisco Department of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
Detailed Description
Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy. Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in this study arm will receive usual care from their primary care clinic.
Arm Title
FIT Outreach + Usual Care
Arm Type
Experimental
Arm Description
Patients in this study arm will receive usual care at their primary care clinic and the intervention.
Intervention Type
Behavioral
Intervention Name(s)
FIT Outreach
Intervention Description
This arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using.
Primary Outcome Measure Information:
Title
Completion of FIT- one year
Description
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incomplete FIT- 28 days
Description
Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
Time Frame
28 days
Title
FIT Positive
Description
Among the patients that have completed the FIT the percentage that had a positive FIT test.
Time Frame
1 year
Title
Completed Colonoscopy
Description
Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
Time Frame
One year
Title
Colonoscopy Findings
Description
Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
Time Frame
One year
Title
Cost
Description
How much the program costed to start and the costs throughout program implementation.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Asymptomatic men and women 50 to 75 years of age Exclusion Criteria: Personal history of polyps requiring colonoscopic surveillance Homeless Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Somsouk, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco-San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34280552
Citation
Lee B, Keyes E, Rachocki C, Grimes B, Chen E, Vittinghoff E, Ladabaum U, Somsouk M. Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1326-1333.e4. doi: 10.1016/j.cgh.2021.07.022. Epub 2021 Jul 16.
Results Reference
derived
PubMed Identifier
30503967
Citation
Wang A, Rachocki C, Shapiro JA, Issaka RB, Somsouk M. Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1822-1828. doi: 10.1016/j.cgh.2018.11.050. Epub 2018 Nov 29.
Results Reference
derived

Learn more about this trial

Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System

We'll reach out to this number within 24 hrs