NCT02613260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

November 20, 2015

Last Update Submit

August 8, 2019

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (5)

  • Incomplete FIT- 28 days

    28 days

  • FIT Positive

    1 year

  • Completed Colonoscopy

    One year

  • Colonoscopy Findings

    One year

  • Cost

    Two years

Study Arms (2)

Usual Care

NO INTERVENTION

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

FIT Outreach + Usual Care

EXPERIMENTAL

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

Behavioral: FIT Outreach

Interventions

FIT OutreachBEHAVIORAL

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.

FIT Outreach + Usual Care

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic men and women
  • to 75 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco-San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (3)

  • McClellan SP, Canchola AJ, Potter MB, Gomez SL, Somsouk M. Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial. Prev Med. 2023 Feb;167:107388. doi: 10.1016/j.ypmed.2022.107388. Epub 2022 Dec 14.

    PMID: 36528113DERIVED

  • 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.

    PMID: 34280552DERIVED

  • 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.

    PMID: 30503967DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ma Somsouk, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

January 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

US(1)