Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC)

This study is not yet open for participant recruitment.
Verified November 2012 by Kaiser Permanente
Sponsor:
Collaborators:
Group Health
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01742065
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: November 2012
  Purpose

Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.

This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.


Condition Intervention Phase
Colorectal Cancer
Behavioral: Auto
Other: Auto Plus
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Increased Screening Rates [ Time Frame: up to 4 years (study period) ] [ Designated as safety issue: No ]
    Investigators will determine if the auto and auto-plus interventions increase the rates of screening compared to usual care at FQHC clinics.


Estimated Enrollment: 2000
Study Start Date: January 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.
Active Comparator: Auto
Clinics randomized to the Auto arm will send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit.
Behavioral: Auto
Clinics randomized to the Auto arm will send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit.
Active Comparator: Auto Plus
Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.
Other: Auto Plus
Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 50-74 with no evidence of a colonoscopy within 9 years or a FIT within 11 months will be eligible to receive a mailed FIT.

Exclusion Criteria:

  • Colonoscopy within 9 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742065

Contacts
Contact: Amanda F Petrik, MS 503-335-2483 amanda.f.petrik@kpchr.org
Contact: Jennifer J Sanchez, MS Jennifer.J.Sanchez@kpchr.org

Locations
United States, Oregon
Virginia Garcia Memorial Health Center Not yet recruiting
Hillsboro, Oregon, United States, 97124
Contact: Tanya Kapka, MD         tanya.kapka@kpchr.org    
Sub-Investigator: Tanya Kapka, MD            
Sponsors and Collaborators
Kaiser Permanente
Group Health
Investigators
Principal Investigator: Gloria Coronado, PhD The Center for Health Research, Kaiser Permanente Northwest
Principal Investigator: Jennifer DeVoe, MD OCHIN
Principal Investigator: Beverly Green, PhD Group Health Cooperative
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01742065     History of Changes
Other Study ID Numbers: 1UH2AT007782-01, 1UH2AT007782-01
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Colorectal Cancer Screening
Cancer Screening
Pragmatic Trial

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013