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| Sponsor: | Harvard University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00355004 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Other: counseling intervention Procedure: fecal occult blood test Procedure: screening colonoscopy |
| Study Type: | Interventional |
| Study Design: | Screening, Randomized, Active Control |
| Official Title: | Improving Systems for Colorectal Cancer Screening |
| Estimated Enrollment: | 21860 |
| Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
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).
Patients are followed for 15 months to determine screening rates.
PROJECTED ACCRUAL: A total of 21,860 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Receiving primary care at 1 of 11 participating Harvard Vanguard Medical Associates (HVMA) centers
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Massachusetts | |
| Harvard Medical School | |
| Boston, Massachusetts, United States, 02115 | |
| Harvard Pilgrim Health Care | |
| Boston, Massachusetts, United States, 02215 | |
| Harvard Vanguard Medical Associates - Kenmore | |
| Boston, Massachusetts, United States, 02215 | |
| Study Chair: | John Ayanian, MD, MPP | Harvard University |
| Investigator: | Robert H. Fletcher, MD | Harvard Pilgrim Health Care |
More Information
| Study ID Numbers: | CDR0000486405, HMS-M11960-103, HCHP-1305 |
| Study First Received: | July 19, 2006 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00355004 History of Changes |
| Health Authority: | United States: Federal Government |
|
colon cancer rectal cancer |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |