Colorectal CancerNCT00436137
Improving Followup of Abnormal Colon Cancer Screening Tests
A study testing Patient mailing in people with Colorectal Cancer, run by Harvard Vanguard Medical Associates at 1 site in United States.
Trial summary
The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Patient mailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Mar 2008
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result
Who cannot join
- Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
- Colonoscopy within 5 years prior to positive fecal occult blood test
- Age > 80 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Vanguard Medical Associates
Newton, Massachusetts, 02466
About this study
Official title: Improving Followup of Positive Fecal Occult Blood Tests
The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.
Read the detailed description
Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.
- Conditions
- Colorectal Cancer
- Being tested
- Patient mailing
- Keywords
- Colorectal cancer, Fecal occult blood test, Abnormal test result, Missed diagnosis, Delayed diagnosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient mailingBehavioural
Patient will receive a mailing recommending colonoscopy, followed by telephone outreach
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach Receives: Behavioral: Patient mailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of colonoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Vanguard Medical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Thomas D Sequist, MD, MPH, Principal investigator, Harvard Vanguard Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436137
- Sponsor's protocol ID
- Sequist Colorectal Cancer
- Status last verified
- Nov 2008
- First submitted
- 14 Feb 2007
- Last updated
- 6 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Followup of Positive Fecal Occult Blood Tests
- ClinicalTrials.gov ID
- NCT00436137
- Acronym / sponsor ID
- Sequist Colorectal Cancer
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Fecal occult blood test, Abnormal test result, Missed diagnosis, Delayed diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Harvard Vanguard Medical AssociatesUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jun 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Feb 2007 (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.
The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.
Detailed description
Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient mailingPatients will receive a mailing recommending colonoscopy, followed by a telephone outreach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result
Key exclusion criteria (3 listed)
- Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
- Colonoscopy within 5 years prior to positive fecal occult blood test
- Age > 80 years
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 |
|---|---|---|
| Patient mailingPatient will receive a mailing recommending colonoscopy, followed by telephone outreach | Behavioural | 1 |
Primary outcome
Performance of colonoscopy
Time frame: 6 months
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 6 Nov 2008.
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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.
Thomas D Sequist, MD, MPH principal investigator
Harvard Vanguard Medical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient mailing in people with Colorectal Cancer, run by Harvard Vanguard Medical Associates at 1 site 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?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Performance of colonoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2008.