Colorectal CancerNCT01211379
The FLU-FOBT Program in Primary Care Settings Where Disparities Persist
A study testing FLU-FOBT Program in people with Colorectal Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators overall goals are to adapt, implement, evaluate, and disseminate the FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce colorectal cancer screening disparities in resource-poor clinical settings. 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?
- FLU-FOBT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,372 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 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
Who may be able to join
- Participants must be primary care patients one of 6 participating clinics
- Participants must be aged 50-75
- Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: The FLU-FOBT Program: Translation of an Evidence-Based Colorectal Cancer Screening Program to Primary Care Settings Where Disparities Persist
The investigators overall goals are to adapt, implement, evaluate, and disseminate the FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce colorectal cancer screening disparities in resource-poor clinical settings. In this program, fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates of colorectal cancer screening (CRCS).
Read the detailed description
AIM 1 (Year 1): To adapt and pilot test the FLU-FOBT Program as a nurse-run intervention during primary care visits at San Francisco's Chinatown Public Health Center. The FLU-FOBT Program will be designed in such a way as to trigger the offering of fecal occult blood testing (FOBT) to eligible patients whenever an influenza vaccination (FLU) is provided. Specific components of the FLU-FOBT Program will be developed through a process of active collaboration with health center staff. The FLU-FOBT Program will be implemented in the fall of 2008-9 and evaluated with a combination of process measures in Year 1 of the study. This formative work will be used to finalize the FLU-FOBT Program for further study of its efficacy and robustness in other affiliated San Francisco public health centers.
AIM 2 (Year 2 and 3): To test the efficacy of the FLU-FOBT Program in improving colorectal cancer screening rates in a time-randomized, controlled trial involving other public health centers in the San Francisco Community Health Network that serve ethnically diverse, economically disadvantaged patients. During the 2009-10 influenza vaccination season, the FLU-FOBT Program will be tested in a randomized trial within 6 public health centers in San Francisco. On half of randomly selected dates at each of these clinics, a nurse will follow a protocol that directs them to offer FOBT to eligible patients whenever they are offered an influenza vaccine (intervention), and on the other dates nurses will be directed to offer just influenza vaccine alone (control). The primary efficacy outcome will be the proportion of intervention subjects between the ages of 50 and 80 and are initially due for CRCS who become up to date 3 months after the intervention is completed, as compared with similar subjects in the control group.
AIM 3 (Years 2 and 3): To evaluate the robustness of the FLU-FOBT Program as implemented within these 6 clinics. In the 2009-10 influenza vaccination season, we will also test the robustness of the FLU-FOBT Program as implemented at the 6 sites that participate in the time-randomized trial. Robustness will be measured according to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) described by Glasgow and others [2]. Reach will be measured as the proportion of the target population that is offered screening, and Effectiveness will be measured as the proportion of the target population that gets screened with the intervention. Adoption will be measured as the proportion of invited influenza vaccination clinic sites and clinic staff members that participate; Implementation will be assessed according to the fidelity with which participating sites and clinic staff follow the key elements of FLU-FOBT Program protocol and how they adapt the protocol to accommodate local needs and constraints. Maintenance will be assessed by determining the number of intervention sites that continue the FLU-FOBT Program in the year after the intervention has been completed, and the overall success of the program where it is continued.
AIM 4 (Year 3): To develop a FLU-FOBT Program Toolkit that can be adopted locally and disseminated to other public health clinics that rely on annual FOBT as a primary strategy for average risk colorectal cancer screening. Study results from all participating health centers will be used to develop an evidence-based FLU-FOBT Toolkit that can be distributed and serve as a practical guide for clinical decision makers who wish to adapt and replicate this intervention within clinics that serve diverse communities that experience disparities in colorectal cancer screening. The Toolkit will include both key elements that must be preserved in order for the FLU-FOBT Program to be successful, as well as examples of enhancements successfully implemented in different clinics
- Conditions
- Colorectal Cancer
- Being tested
- FLU-FOBT Program
- Keywords
- colorectal cancer screening, primary care, health disparities
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLU-FOBT ProgramBehavioural
Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
| Study group | Role | What they receive |
|---|---|---|
| FLU-Only Arm | No intervention | In this arm, primary care patients who got flu shots were only provided with FOBT if the doctor decided to order it. |
| FLU-FOBT Arm | Experimental | In this arm, patients who came in for primary care got a flu shot and were assessed by nurses for eligibility for colorectal cancer screening. Eligible patients were provided with home FOBT. Receives: Behavioral: FLU-FOBT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Colorectal Cancer Screening Rate
Change in colorectal cancer screening rates (defined as being up to date with FOBT in the last 12 months, up to date with flexible sigmoidoscopy within the last 5 years, or up to date with colonoscopy in the last 10 years) by March 30, 2010, 6 months after the beginning of the intervention.
Measured: March 30, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionAug 2010
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 University of California, San FranciscoThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Department of Public Health, Centers for Disease Control and Prevention
- Investigators
- Michael B. Potter, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211379
- Sponsor's protocol ID
- 1R18DP001566-01
- Status last verified
- Sep 2010
- First submitted
- 25 Sep 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Potter MB, Walsh JM, Yu TM, Gildengorin G, Green LW, McPhee SJ. The effectiveness of the FLU-FOBT program in primary care a randomized trial. Am J Prev Med. 2011 Jul;41(1):9-16. doi: 10.1016/j.amepre.2011.03.011.
PubMed 21665058
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FLU-FOBT Program: Translation of an Evidence-Based Colorectal Cancer Screening Program to Primary Care Settings Where Disparities Persist
- ClinicalTrials.gov ID
- NCT01211379
- Acronym / sponsor ID
- 1R18DP001566-01
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, primary care, health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,372 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Department of Public Health, Centers for Disease Control and Prevention
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Sep 2010 (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 investigators overall goals are to adapt, implement, evaluate, and disseminate the FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce colorectal cancer screening disparities in resource-poor clinical settings. In this program, fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates of colorectal cancer screening (CRCS).
Detailed description
AIM 1 (Year 1): To adapt and pilot test the FLU-FOBT Program as a nurse-run intervention during primary care visits at San Francisco's Chinatown Public Health Center. The FLU-FOBT Program will be designed in such a way as to trigger the offering of fecal occult blood testing (FOBT) to eligible patients whenever an influenza vaccination (FLU) is provided. Specific components of the FLU-FOBT Program will be developed through a process of active collaboration with health center staff. The FLU-FOBT Program will be implemented in the fall of 2008-9 and evaluated with a combination of process measures in Year 1 of the study. This formative work will be used to finalize the FLU-FOBT Program for further study of its efficacy and robustness in other affiliated San Francisco public health centers.
AIM 2 (Year 2 and 3): To test the efficacy of the FLU-FOBT Program in improving colorectal cancer screening rates in a time-randomized, controlled trial involving other public health centers in the San Francisco Community Health Network that serve ethnically diverse, economically disadvantaged patients. During the 2009-10 influenza vaccination season, the FLU-FOBT Program will be tested in a randomized trial within 6 public health centers in San Francisco. On half of randomly selected dates at each of these clinics, a nurse will follow a protocol that directs them to offer FOBT to eligible patients whenever they are offered an influenza vaccine (intervention), and on the other dates nurses will be directed to offer just influenza vaccine alone (control). The primary efficacy outcome will be the proportion of intervention subjects between the ages of 50 and 80 and are initially due for CRCS who become up to date 3 months after the intervention is completed, as compared with similar subjects in the control group.
AIM 3 (Years 2 and 3): To evaluate the robustness of the FLU-FOBT Program as implemented within these 6 clinics. In the 2009-10 influenza vaccination season, we will also test the robustness of the FLU-FOBT Program as implemented at the 6 sites that participate in the time-randomized trial. Robustness will be measured according to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) described by Glasgow and others [2]. Reach will be measured as the proportion of the target population that is offered screening, and Effectiveness will be measured as the proportion of the target population that gets screened with the intervention. Adoption will be measured as the proportion of invited influenza vaccination clinic sites and clinic staff members that participate; Implementation will be assessed according to the fidelity with which participating sites and clinic staff follow the key elements of FLU-FOBT Program protocol and how they adapt the protocol to accommodate local needs and constraints. Maintenance will be assessed by determining the number of intervention sites that continue the FLU-FOBT Program in the year after the intervention has been completed, and the overall success of the program where it is continued.
AIM 4 (Year 3): To develop a FLU-FOBT Program Toolkit that can be adopted locally and disseminated to other public health clinics that rely on annual FOBT as a primary strategy for average risk colorectal cancer screening. Study results from all participating health centers will be used to develop an evidence-based FLU-FOBT Toolkit that can be distributed and serve as a practical guide for clinical decision makers who wish to adapt and replicate this intervention within clinics that serve diverse communities that experience disparities in colorectal cancer screening. The Toolkit will include both key elements that must be preserved in order for the FLU-FOBT Program to be successful, as well as examples of enhancements successfully implemented in different clinics
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLU-Only Arm | No intervention | –In this arm, primary care patients who got flu shots were only provided with FOBT if the doctor decided to order it. |
| FLU-FOBT Arm | Experimental | Behavioral: FLU-FOBT ProgramIn this arm, patients who came in for primary care got a flu shot and were assessed by nurses for eligibility for colorectal cancer screening. Eligible patients were provided with home FOBT. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be primary care patients one of 6 participating clinics
- Participants must be aged 50-75
- Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FLU-FOBT ProgramPrimary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due. | Behavioural | FLU-FOBT Arm |
Primary outcome
Change in Colorectal Cancer Screening Rate
Time frame: March 30, 2010
Change in colorectal cancer screening rates (defined as being up to date with FOBT in the last 12 months, up to date with flexible sigmoidoscopy within the last 5 years, or up to date with colonoscopy in the last 10 years) by March 30, 2010, 6 months after the beginning of the intervention.
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 18 Oct 2010.
- Derived from this study: PubMed 21665058Potter MB, Walsh JM, Yu TM, Gildengorin G, Green LW, McPhee SJ. The effectiveness of the FLU-FOBT program in primary care a randomized trial. Am J Prev Med. 2011 Jul;41(1):9-16. doi: 10.1016/j.amepre.2011.03.011.
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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.
Michael B. Potter, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLU-FOBT Program in people with Colorectal Cancer, run by University of California, San Francisco 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 3 inclusion and 0 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 18 Oct 2010. 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?
Change in Colorectal Cancer Screening Rate (time frame: March 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 NCT01211379, 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 Oct 2010.