Colorectal CancerNCT01032746
Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer
A study testing educational intervention, internet-based intervention and evaluation of cancer risk factors in people with Colorectal Cancer, run by Harvard University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- educational intervention, internet-based intervention and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Harvard Medical School
Boston, Massachusetts, 02115
John Ayanian, MD, MPP, 617-432-3455
- Recruiting
Harvard Vanguard Medical Associates - Kenmore
Boston, Massachusetts, 02215
Thomas D. Sequist, MD, MPH, 617-432-3447, tsequist@partners.org
About this study
Official title: Use of a Personal Health Record to Improve Colorectal Cancer Screening
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- educational intervention, internet-based intervention, evaluation of cancer risk factors, fecal occult blood test, screening colonoscopy
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
internet-based interventionOther
evaluation of cancer risk factorsProcedure or surgery
fecal occult blood testProcedure or surgery
screening colonoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startMar 2005
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John Ayanian, MD, MPP, Study chair, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032746
- Sponsor's protocol ID
- CDR0000661288
- Other IDs
- HMS-11960
- Status last verified
- Jun 2011
- First submitted
- 13 Dec 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Sequist TD, Zaslavsky AM, Colditz GA, Ayanian JZ. Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):636-41. doi: 10.1001/archinternmed.2010.467. Epub 2010 Dec 13.
PubMed 21149743
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Personal Health Record to Improve Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT01032746
- Acronym / sponsor ID
- CDR0000661288
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Sep 2010 (estimated)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | – |
| internet-based intervention | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
| fecal occult blood test | Procedure or surgery | – |
| screening colonoscopy | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Results publication: PubMed 21149743Sequist TD, Zaslavsky AM, Colditz GA, Ayanian JZ. Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):636-41. doi: 10.1001/archinternmed.2010.467. Epub 2010 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Ayanian, MD, MPP study chair
Harvard Medical School (HMS and HSDM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, internet-based intervention and evaluation of cancer risk factors in people with Colorectal Cancer, run by Harvard University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.