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Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Harvard University
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01032746
First received: December 13, 2009
Last updated: December 17, 2013
Last verified: June 2011
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Purpose
RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for colorectal cancer.
PURPOSE: This randomized clinical trial is studying personal electronic health records to see how well they work in improving screening rates for colorectal cancer.
| Condition | Intervention |
|---|---|
| Colorectal Cancer | Other: educational intervention Other: internet-based intervention Procedure: evaluation of cancer risk factors Procedure: fecal occult blood test Procedure: screening colonoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Screening |
| Official Title: | Use of a Personal Health Record to Improve Colorectal Cancer Screening |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
Secondary Outcome Measures:
- Proportion of participants who access the web-based risk-assessment tool
- Distribution of risk-status among participants who complete the web-based risk-assessment tool
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To assess whether screening rates for colorectal cancer (CRC) can be substantially increased among adults in primary care through the use of a personal electronic health record that provides a link to a validated web-based tool to estimate an individual's risk of CRC and electronic scheduling of CRC screening exams.
OUTLINE: This is a multicenter study. Participants are stratified according to participating Harvard Vanguard Medical Associates (HVMA) center. Participants are randomized to 1 of 2 arms.
- Intervention arm: Participants receive an electronic message within their MyHealth account on behalf of their primary care physician providing a link to a web-based tool to allow them to assess their personal risk of colorectal cancer (CRC). The tool provides an estimate of an individual's personal risk of developing different types of cancer over the next 10 years relative to others of the same age and sex. The tool also recommends steps that individuals can take to reduce their risk. The tool includes questions about family history; prior screening tests; dietary habits (red meat, fruits, and vegetables); weight and height; and use of folate, aspirin, estrogen therapy, alcohol, and tobacco. In addition, the electronic message provides information regarding options for CRC screening, emphasizing colonoscopy every 10 years per the current HVMA guidelines, followed by the secondary recommendation of annual fecal occult blood testing. Detailed information is provided in the form of a link to online educational materials. Participants may request either colonoscopy or fecal occult blood testing by responding to the electronic message and indicating their preference. Participants who request colonoscopy are contacted by the gastroenterology department to proceed with CRC screening; participants who request fecal occult blood testing will receive a stool card test kit in the mail from their primary care physician.
- Control arm: Participants receive no intervention.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
-
Overdue for colorectal cancer screening (identified using automated extracts from the electronic medical record), as defined by the following criteria:
- No fecal occult blood test within the past 12 months
- No flexible sigmoidoscopy within the past 5 years
- No colonoscopy within the past 10 years
- Receiving primary care at a Harvard Vanguard Medical Associates (HVMA) center
- Registered to use the HVMA patient portal (MyHealth) AND has an active MyHealth account
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032746
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032746
Locations
| United States, Massachusetts | |
| Harvard Medical School | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: John Ayanian, MD, MPP 617-432-3455 | |
| Harvard Vanguard Medical Associates - Kenmore | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Thomas D. Sequist, MD, MPH 617-432-3447 tsequist@partners.org | |
Sponsors and Collaborators
Harvard University
National Cancer Institute (NCI)
Investigators
| Study Chair: | John Ayanian, MD, MPP | Harvard Medical School |
More Information
Publications:
| Responsible Party: | John Ayanian, Harvard Medical School |
| ClinicalTrials.gov Identifier: | NCT01032746 History of Changes |
| Other Study ID Numbers: |
CDR0000661288 HMS-11960 |
| Study First Received: | December 13, 2009 |
| Last Updated: | December 17, 2013 |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
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 June 23, 2017