Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size
Trial record 5 of 8 for:    Open Studies | "Health Records, Personal"
Previous Study | Return to List | Next Study

Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants who access the web-based risk-assessment tool [ Designated as safety issue: No ]
  • Distribution of risk-status among participants who complete the web-based risk-assessment tool [ Designated as safety issue: No ]
Estimated Enrollment: 1000
Study Start Date: March 2005
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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)
Genders Eligible for Study:   Both
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

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
Health Authority: Unspecified

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 September 23, 2016