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Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
fecal occult blood test
screening colonoscopy
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS: Receiving primary care at 1 of 11 participating Harvard Vanguard Medical Associates (HVMA) centers Has an active primary care physician Had a primary care visit within the past 18 months Is due for colorectal cancer screening PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Sites / Locations

  • Harvard Medical School
  • Harvard Pilgrim Health Care
  • Harvard Vanguard Medical Associates - Kenmore

Outcomes

Primary Outcome Measures

Rate of colorectal cancer screening

Secondary Outcome Measures

Number of patients with adenomatous polyps and colon cancer diagnosed
Number of stool cards returned and abnormal stool cards
Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

Full Information

First Posted
July 19, 2006
Last Updated
December 18, 2013
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00355004
Brief Title
Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer
Official Title
Improving Systems for Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Computerized and mailed reminders may help increase the rate of colorectal cancer screening in adults with an average risk for colorectal cancer. PURPOSE: This randomized clinical trial is studying how well computerized and mailed reminders work in increasing the rate of colorectal cancer screening in adults with an average risk for colorectal cancer.
Detailed Description
OBJECTIVES: Primary Determine whether rates of colorectal cancer (CRC) screening can be increased among average-risk adults by using patient-specific, active, electronic, clinical reminders for primary care physicians during office visits and mailed reminders and fecal occult blood test cards for patients. Secondary Calculate baseline rates of CRC screening, in terms of patient demographic characteristics, primary care physician, and practice group, by using computerized clinical information systems to identify patients due for screening. Assess baseline rates of CRC screening among patients insured by different health plans. Determine whether the impact of the interventions is related to efforts by health plans to promote CRC screening. Evaluate patients' willingness to use a validated web-based tool to estimate their personal risk of CRC. OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 arms (arms I or III). Physicians are randomized to 1 of 2 arms (arms II or IV). Arm I: Patients receive mailed reminders for colorectal cancer (CRC) screening. Patients also receive fecal occult blood testing (FOBT) instructions and cards. Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened. Patients who return positive FOBT cards undergo colonoscopy within 1 month. The patient's primary care physician may receive computerized screening reminders at the time of the patient's office visit and may order CRC screening tests online. Arm II: Patients receive no mailings. The patient's primary care physician may receive computerized screening reminders at the time of the patient's office visit and may order CRC screening tests online. Arm III: Patients receive mailed reminders for CRC screening. The patient's primary care physician may order CRC screening tests online, but will not receive active computerized reminders. Patients also receive FOBT instructions and cards. Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened. Patients who return positive FOBT cards will be scheduled to undergo colonoscopy within 1 month. Arm IV: Patients receive no mailings. The patient's primary care physician may order CRC screening tests online, but will not receive active computerized reminders. Patients are followed for 15 months to determine screening rates. PROJECTED ACCRUAL: A total of 21,860 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
21860 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Procedure
Intervention Name(s)
fecal occult blood test
Intervention Type
Procedure
Intervention Name(s)
screening colonoscopy
Primary Outcome Measure Information:
Title
Rate of colorectal cancer screening
Secondary Outcome Measure Information:
Title
Number of patients with adenomatous polyps and colon cancer diagnosed
Title
Number of stool cards returned and abnormal stool cards
Title
Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Receiving primary care at 1 of 11 participating Harvard Vanguard Medical Associates (HVMA) centers Has an active primary care physician Had a primary care visit within the past 18 months Is due for colorectal cancer screening PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ayanian, MD, MPP
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert H. Fletcher, MD
Organizational Affiliation
Harvard Pilgrim Health Care
Facility Information:
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harvard Pilgrim Health Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Harvard Vanguard Medical Associates - Kenmore
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19237720
Citation
Sequist TD, Zaslavsky AM, Marshall R, Fletcher RH, Ayanian JZ. Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2009 Feb 23;169(4):364-71. doi: 10.1001/archinternmed.2008.564.
Results Reference
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Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer

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