Colorectal CancerPhase 4NCT00441311
Dissemination of Colorectal Cancer Screening to Primary Care Physicians
A Phase 4 study testing Academic Detailing in people with Colorectal Cancer, run by Columbia University at 1 site in United States.
Trial summary
The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently repeated educational program, on increasing recommendations for colorectal cancer screening among primary care providers by comparison to a service-as-usual control. 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?
- Academic Detailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Sep 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Devote at least 50% of their practice to primary care
- Work in the study communities
- Are non-hospital based community practitioners
- Have no immediate plans to retire or to leave their practice.
Who cannot join
- Specialty physicians
- Intend to retire or otherwise leave practice over course of the study
- Other conditions that would preclude meaningful participation
- Not working in study communities
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently repeated educational program, on increasing recommendations for colorectal cancer screening among primary care providers by comparison to a service-as-usual control. The study is a stratified randomized clinical trial of primary care physicians, stratified by distinct urban communities in the New York metropolitan area. The primary outcome is colorectal cancer screening recommendations measured via medical audit at 12-month followup after randomization.
Read the detailed description
The purpose of the present study is to adapt and extend the use of academic detailing to the dissemination of colorectal cancer (CRC) screening findings and guidelines to primary care physicians practicing in selected geographic areas in New York City. Since improving implementation of cancer screening guidelines also involves compliance by patients in completing the recommended tests or examinations, we will also seek to assess knowledge, attitude and screening behaviors of patients visiting primary care practitioners in our sample. Our long-term goal is to reduce colorectal cancer mortality among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.
The specific aims of the study are as follows:
- Aim 1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician CRC screening at 3and 6month postrandomization, compared to the rate observed in a serviceasusual control.
- Aim 2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of CRC screening guidelines to different physician subgroups.
- Aim 3. To conduct cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the CRC intervention implemented in physicians' offices.
- Conditions
- Colorectal Cancer
- Being tested
- Academic Detailing
- Keywords
- colorectal cancer screening, primary care physicians, health disparities, stratified randomized clinical trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic DetailingBehavioural
The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination.
| Study group | Role | What they receive |
|---|---|---|
| Academic Detailing | Experimental | The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination. Receives: Behavioral: Academic Detailing |
| Service-as-Usual | No intervention | Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening recommendations
Measured: Up to 12 months from the time of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startMay 2003
- Primary completionJul 2006
- Study completionSep 2006
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.
- More trials run by Columbia 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Investigators
- Sherri Sheinfeld Gorin, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441311
- Sponsor's protocol ID
- AAAA6315
- Status last verified
- Jan 2011
- First submitted
- 26 Feb 2007
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honda K, Gorin SS. A model of stage of change to recommend colonoscopy among urban primary care physicians. Health Psychol. 2006 Jan;25(1):65-73. doi: 10.1037/0278-6133.25.1.65.
PubMed 16448299
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of Colorectal Cancer Screening to Primary Care Physicians
- ClinicalTrials.gov ID
- NCT00441311
- Acronym / sponsor ID
- AAAA6315
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, primary care physicians, health disparities, stratified randomized clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 28 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 aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently repeated educational program, on increasing recommendations for colorectal cancer screening among primary care providers by comparison to a service-as-usual control. The study is a stratified randomized clinical trial of primary care physicians, stratified by distinct urban communities in the New York metropolitan area. The primary outcome is colorectal cancer screening recommendations measured via medical audit at 12-month followup after randomization.
Detailed description
The purpose of the present study is to adapt and extend the use of academic detailing to the dissemination of colorectal cancer (CRC) screening findings and guidelines to primary care physicians practicing in selected geographic areas in New York City. Since improving implementation of cancer screening guidelines also involves compliance by patients in completing the recommended tests or examinations, we will also seek to assess knowledge, attitude and screening behaviors of patients visiting primary care practitioners in our sample. Our long-term goal is to reduce colorectal cancer mortality among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.
The specific aims of the study are as follows:
- Aim 1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician CRC screening at 3and 6month postrandomization, compared to the rate observed in a serviceasusual control.
- Aim 2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of CRC screening guidelines to different physician subgroups.
- Aim 3. To conduct cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the CRC intervention implemented in physicians' offices.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Academic Detailing | Experimental | Behavioral: Academic DetailingThe academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination. |
| Service-as-Usual | No intervention | –Control Arm |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Devote at least 50% of their practice to primary care
- Work in the study communities
- Are non-hospital based community practitioners
- Have no immediate plans to retire or to leave their practice.
Key exclusion criteria (4 listed)
- Specialty physicians
- Intend to retire or otherwise leave practice over course of the study
- Other conditions that would preclude meaningful participation
- Not working in study communities
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 |
|---|---|---|
| Academic DetailingThe academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination. | Behavioural | Academic Detailing |
Primary outcome
Colorectal cancer screening recommendations
Time frame: Up to 12 months from the time of randomization
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 1 Feb 2011.
- Background: PubMed 16448299Honda K, Gorin SS. A model of stage of change to recommend colonoscopy among urban primary care physicians. Health Psychol. 2006 Jan;25(1):65-73. doi: 10.1037/0278-6133.25.1.65.
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.
Sherri Sheinfeld Gorin, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Academic Detailing in people with Colorectal Cancer, run by Columbia 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 4 inclusion and 4 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 1 Feb 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Colorectal cancer screening recommendations (time frame: Up to 12 months from the time of randomization). 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 NCT00441311, 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 1 Feb 2011.