Skip to main content
OpenTrials
Completed

NCT Number: NCT00355004

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Medical School, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

counseling intervention

Other

fecal occult blood test

Procedure

screening colonoscopy

Procedure

Primary outcomes

  1. Rate of colorectal cancer screening

Secondary outcomes

  1. Number of patients with adenomatous polyps and colon cancer diagnosed

  2. Number of stool cards returned and abnormal stool cards

  3. Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improving Systems for Colorectal Cancer Screening

Important dates

Study start
2005
Study completion
2009
First posted
Jul 20, 2006
Registry last updated
Dec 19, 2013

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.

Published trials that share one or more normalized conditions with this study.