Malignant Neoplasm of Large IntestineNCT01385579
Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population
A study testing Care manager outreach in people with Malignant Neoplasm of Large Intestine, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of Large Intestine
- What is being tested?
- Care manager outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009
Who cannot join
- Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)
Trial locations and contacts
1 site in 1 country.
United States1 site
Heartland International Health Center
Chicago, Illinois, 60645
About this study
Official title: A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population
The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.
Read the detailed description
Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.
- Conditions
- Malignant Neoplasm of Large Intestine
- Being tested
- Care manager outreach
- Keywords
- colorectal cancer screening, fecal occult blood testing (FOBT), vulnerable populations, community health center
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care manager outreachOther
Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. |
| Care manager outreach | Experimental | Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit Receives: Other: Care manager outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of a Colorectal Cancer Screening
Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)
Measured: within 4 months of the initiation of outreach (by June 30, 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Large IntestineStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bechara Choucair, Northwestern University
- Investigators
- Bechara N Choucair, MD, Principal investigator, Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385579
- Sponsor's protocol ID
- STU00015652
- Status last verified
- Nov 2013
- First submitted
- 28 Jun 2011
- Last updated
- 6 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381.
PubMed 22966104
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population
- ClinicalTrials.gov ID
- NCT01385579
- Acronym / sponsor ID
- STU00015652
- Conditions
- Malignant Neoplasm of Large Intestine
- Keywords
- colorectal cancer screening, fecal occult blood testing (FOBT), vulnerable populations, community health center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Posted 6 Jan 2014
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 if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.
Detailed description
Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. |
| Care manager outreach | Experimental | Other: Care manager outreachPatients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009
Key exclusion criteria (1 listed)
- Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)
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 |
|---|---|---|
| Care manager outreachPatients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager. | Other | Care manager outreach |
Primary outcome
Completion of a Colorectal Cancer Screening
Time frame: within 4 months of the initiation of outreach (by June 30, 2010)
Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22966104Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381.
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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.
Bechara N Choucair, MD principal investigator
Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care manager outreach in people with Malignant Neoplasm of Large Intestine, run by Northwestern University 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 1 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 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion of a Colorectal Cancer Screening (time frame: within 4 months of the initiation of outreach (by June 30, 2010)). 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 NCT01385579, 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 6 Jan 2014.