Colorectal CancerNCT00355004
Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer
A study testing counseling intervention, fecal occult blood test and screening colonoscopy in people with Colorectal Cancer, run by Harvard Medical School (HMS and HSDM) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- counseling intervention, fecal occult blood test and screening colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 21,860 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2005to Feb 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard Medical School
Boston, Massachusetts, 02115
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
Harvard Vanguard Medical Associates - Kenmore
Boston, Massachusetts, 02215
About this study
Official title: Improving Systems for Colorectal Cancer Screening
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- counseling intervention, 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.
counseling interventionOther
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.
Rate of colorectal cancer screening
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startMar 2005
- Study completionFeb 2009
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
- 21,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John Ayanian, MD, MPP, Study chair, Harvard Medical School (HMS and HSDM)Robert H. Fletcher, MD, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355004
- Sponsor's protocol ID
- CDR0000486405
- Other IDs
- HMS-M11960-103, HCHP-1305
- Status last verified
- Jan 2007
- First submitted
- 19 Jul 2006
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
Sequist TD, Zaslavsky AM, Marshall R, Fletcher RH, Ayanian JZ. Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2009 Feb 23;169(4):364-71. doi: 10.1001/archinternmed.2008.564.
PubMed 19237720
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Systems for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT00355004
- Acronym / sponsor ID
- CDR0000486405
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,860 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Jul 2006 (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: 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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 80 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 |
|---|---|---|
| counseling intervention | Other | – |
| fecal occult blood test | Procedure or surgery | – |
| screening colonoscopy | Procedure or surgery | – |
Primary outcome
Rate of colorectal cancer screening
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Results publication: PubMed 19237720Sequist TD, Zaslavsky AM, Marshall R, Fletcher RH, Ayanian JZ. Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2009 Feb 23;169(4):364-71. doi: 10.1001/archinternmed.2008.564.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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)
Robert H. Fletcher, MD
Harvard Pilgrim Health Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, fecal occult blood test and screening colonoscopy in people with Colorectal Cancer, run by Harvard Medical School (HMS and HSDM) at 3 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: finished, as of the sponsor's last update on 19 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of colorectal cancer screening. 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 NCT00355004, 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 19 Dec 2013.