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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
fecal occult blood test
Procedurescreening colonoscopy
ProcedurePrimary outcomes
-
Rate of colorectal cancer screening
Secondary outcomes
-
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
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
NCT07725692
Anastomotic Leak, Colon Cancer
Alexandria, Please Select, Egypt
View Trial DetailsColonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
NCT00102011
Colonic Diseases, Colonic Neoplasms
Shreveport, Louisiana, United States
View Trial DetailsCetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
NCT00556413
Colonic Diseases, Colonic Neoplasms
Montpellier, France
View Trial DetailsPeLear CCC: Proyecto Latino Contra Cancer Colorrectal
NCT06426927
Colon Adenocarcinoma, Colon Cancer
Chapel Hill, North Carolina, United States
View Trial Details