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Completed

NCT Number: NCT02613260

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

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.

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Key information

Conditions

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

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco-San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FIT Outreach

Behavioral

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 outcomes

  1. Completion of FIT- one year

    Time frame: One year

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

Secondary outcomes

  1. Incomplete FIT- 28 days

    Time frame: 28 days

    Of the patients mailed the FIT kit the number of patients that have not completed their FIT.

  2. FIT Positive

    Time frame: 1 year

    Among the patients that have completed the FIT the percentage that had a positive FIT test.

  3. Completed Colonoscopy

    Time frame: One year

    Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.

  4. Colonoscopy Findings

    Time frame: One year

    Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).

  5. Cost

    Time frame: Two years

    How much the program costed to start and the costs throughout program implementation.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Department of Public Health
  • Stanford University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 24, 2015
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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