Colorectal Cancer ScreeningNCT00705731
Adherence and the Economics of Colon Cancer Screening
An observational study of Colorectal Cancer Screening, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will compare patient adherence to different colorectal cancer (CRC) screening tests to identify the most cost-effective strategy to decrease mortality from CRC. We hypothesize that different types of tests will have different adherence rates, that these rates will alter the cost-effectiveness analysis, and… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2011
- Phase
- Observational
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population of users of outpatient primary care clinics at San Francisco General Hospital at average risk for development of colorectal cancer (CRC). Outpatient clinics include the General Medical Clinic, the Family Health Center, and the Positive Health Program (HIV primary care clinic).
Who may be able to join
- Average-risk subjects (no family history of CRC, no personal history of polyps or CRC).
- 50 years of age or greater, but less than 80 years old.
- Due for CRC screening.
- Upcoming appointment scheduled with primary care provider.
- Primary care provider has agreed to refer patients for consideration of enrollment in the study.
Who cannot join
- Family history of CRC in a first-degree relative.
- Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease.
- Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain).
- CRC screening current (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
- Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
This study will compare patient adherence to different colorectal cancer (CRC) screening tests to identify the most cost-effective strategy to decrease mortality from CRC. We hypothesize that different types of tests will have different adherence rates, that these rates will alter the cost-effectiveness analysis, and that we can identify patient variables associated with non-adherence to specific CRC screening strategies.
Read the detailed description
Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening rates remain low. Previous investigators have identified barriers to adherence to CRC screening; however, the majority of data have been retrospectively derived, and the limited data produced from prospective assessment have been limited to fecal occult blood testing (FOBT). Constructs based on the Health Belief Model have been proposed to identify items associated with non-adherence to CRC screening, but prospective validation of this model is lacking. The U.S. Preventive Services Task Force report cites a major cause of uncertainty for calculation of the incremental cost-effectiveness of CRC screening is the deficit in primary data regarding adherence to CRC screening tests, specifically whether heterogeneity exists in screening rates of competing strategies. The Institute of Medicine confirmed the importance of detecting heterogeneity in adherence between strategies, understanding that some strategies currently recommended for CRC screening may be dominated by strategies that achieve greater levels of adherence.
This study aims to determine whether adherence rates to CRC screening are heterogeneous between competing strategies (FOBT and colonoscopy). This study will also prospectively examine domains of the Health Belief Model to identify associations with non-adherence to screening. Adherence rates specific to tested strategies will be incorporated in our existing economic models to compare the incremental cost-effectiveness of competing CRC screening strategies. These data will greatly impact policy decisions regarding resource allocation for CRC screening. It is also expected that future research based on data generated through this project will aim to develop and test interventions that optimize adherence to screening strategies to decrease mortality from CRC.
Procedures:
Patients who are due for CRC screening and meet eligibility requirements are identified through a query of the electronic medical record database at San Francisco General Hospital (SFGH). A research assistant (RA) obtains the PCP's approval to attempt recruitment at the patient's primary care appointment. The PCP discusses CRC screening with the participant during their regularly scheduled appointment.
Availability of CRC screening tests: Because of capacity constraints in the endoscopy unit at SFGH, the screening method for those at average risk of CRC had been limited to annual fecal occult blood testing (FOBT). However, the gastroenterology department initiated a pilot program which allows different primary care clinics to refer average-risk patients for colonoscopy screening in rotating 3-month time-blocks. To ensure the endoscopy unit has sufficient capacity to provide CRC screening via colonoscopy, providers in a given primary care clinic are able to refer their patients for (a) colonoscopy screening, (b) FOBT screening, or (c) a choice of either colonoscopy or FOBT screening, depending on the time block. This is not a study intervention; providers simply recommend that their patients complete a standard CRC screening test, and discuss the option or options available. Patients who decline to participate in the study undergo colorectal cancer screening under the guidance of their primary care provider; the same screening tests are available to those who participate and those who do not.
After giving written informed consent, participants complete an RA-administered 20-minute survey based on constructs of the Health Belief Model. Participants also grant us approval to review their medical records in one year to determine if they complete screening; those without a record of testing are contacted to determine if they completed testing outside of SFGH.
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer (CRC), Colorectal cancer screening, Colonoscopy, Fecal occult blood test (FOBT), Cost-effectiveness
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to colorectal cancer (CRC) screening, defined as completion of the screening strategy (the subject agrees to pursue/scheduled by the primary care provider).
Initial adherence measured at one year following enrollment. We have secured additional study funding that will allow us to extend the follow-up period for two more years, so we will measure programmatic adherence to CRC screening strategy over a 3-year period.
Measured: one year, and then annually for two more years
Secondary outcomes (3)
Preventive Intention: Of those who agree to colonoscopy or FOBT, the proportion of patients who have colonoscopy scheduled or take home FOBT cards.
Measured: one year
Preventive Behavior: Of the subjects with a positive FOBT result, determine the proportion adhering to the follow-up colonoscopy.
Measured: one year
Identification of variables in the survey (based on the Health Belief Model) which are associated with non-adherence to screening.
Measured: one yearone year, and then annually for two more years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionNov 2011
- Study completionNov 2011
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 Cancer ScreeningStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Hal F Yee, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705731
- Sponsor's protocol ID
- A105658
- Other IDs
- R01CA106773, K24DK080941, 3R01CA106773-04S1
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2008
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Inadomi JM, Vijan S, Janz NK, Fagerlin A, Thomas JP, Lin YV, Munoz R, Lau C, Somsouk M, El-Nachef N, Hayward RA. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012 Apr 9;172(7):575-82. doi: 10.1001/archinternmed.2012.332.
PubMed 22493463
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and the Economics of Colon Cancer Screening
- ClinicalTrials.gov ID
- NCT00705731
- Acronym / sponsor ID
- A105658
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer (CRC), Colorectal cancer screening, Colonoscopy, Fecal occult blood test (FOBT), Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Jun 2008 (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.
This study will compare patient adherence to different colorectal cancer (CRC) screening tests to identify the most cost-effective strategy to decrease mortality from CRC. We hypothesize that different types of tests will have different adherence rates, that these rates will alter the cost-effectiveness analysis, and that we can identify patient variables associated with non-adherence to specific CRC screening strategies.
Detailed description
Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening rates remain low. Previous investigators have identified barriers to adherence to CRC screening; however, the majority of data have been retrospectively derived, and the limited data produced from prospective assessment have been limited to fecal occult blood testing (FOBT). Constructs based on the Health Belief Model have been proposed to identify items associated with non-adherence to CRC screening, but prospective validation of this model is lacking. The U.S. Preventive Services Task Force report cites a major cause of uncertainty for calculation of the incremental cost-effectiveness of CRC screening is the deficit in primary data regarding adherence to CRC screening tests, specifically whether heterogeneity exists in screening rates of competing strategies. The Institute of Medicine confirmed the importance of detecting heterogeneity in adherence between strategies, understanding that some strategies currently recommended for CRC screening may be dominated by strategies that achieve greater levels of adherence.
This study aims to determine whether adherence rates to CRC screening are heterogeneous between competing strategies (FOBT and colonoscopy). This study will also prospectively examine domains of the Health Belief Model to identify associations with non-adherence to screening. Adherence rates specific to tested strategies will be incorporated in our existing economic models to compare the incremental cost-effectiveness of competing CRC screening strategies. These data will greatly impact policy decisions regarding resource allocation for CRC screening. It is also expected that future research based on data generated through this project will aim to develop and test interventions that optimize adherence to screening strategies to decrease mortality from CRC.
Procedures:
Patients who are due for CRC screening and meet eligibility requirements are identified through a query of the electronic medical record database at San Francisco General Hospital (SFGH). A research assistant (RA) obtains the PCP's approval to attempt recruitment at the patient's primary care appointment. The PCP discusses CRC screening with the participant during their regularly scheduled appointment.
Availability of CRC screening tests: Because of capacity constraints in the endoscopy unit at SFGH, the screening method for those at average risk of CRC had been limited to annual fecal occult blood testing (FOBT). However, the gastroenterology department initiated a pilot program which allows different primary care clinics to refer average-risk patients for colonoscopy screening in rotating 3-month time-blocks. To ensure the endoscopy unit has sufficient capacity to provide CRC screening via colonoscopy, providers in a given primary care clinic are able to refer their patients for (a) colonoscopy screening, (b) FOBT screening, or (c) a choice of either colonoscopy or FOBT screening, depending on the time block. This is not a study intervention; providers simply recommend that their patients complete a standard CRC screening test, and discuss the option or options available. Patients who decline to participate in the study undergo colorectal cancer screening under the guidance of their primary care provider; the same screening tests are available to those who participate and those who do not.
After giving written informed consent, participants complete an RA-administered 20-minute survey based on constructs of the Health Belief Model. Participants also grant us approval to review their medical records in one year to determine if they complete screening; those without a record of testing are contacted to determine if they completed testing outside of SFGH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population of users of outpatient primary care clinics at San Francisco General Hospital at average risk for development of colorectal cancer (CRC). Outpatient clinics include the General Medical Clinic, the Family Health Center, and the Positive Health Program (HIV primary care clinic).
Key inclusion criteria (5 listed)
- Average-risk subjects (no family history of CRC, no personal history of polyps or CRC).
- 50 years of age or greater, but less than 80 years old.
- Due for CRC screening.
- Upcoming appointment scheduled with primary care provider.
- Primary care provider has agreed to refer patients for consideration of enrollment in the study.
Key exclusion criteria (5 listed)
- Family history of CRC in a first-degree relative.
- Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease.
- Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain).
- CRC screening current (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
- Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to colorectal cancer (CRC) screening, defined as completion of the screening strategy (the subject agrees to pursue/scheduled by the primary care provider).
Time frame: one year, and then annually for two more years
Initial adherence measured at one year following enrollment. We have secured additional study funding that will allow us to extend the follow-up period for two more years, so we will measure programmatic adherence to CRC screening strategy over a 3-year period.
3 secondary outcomes
Preventive Intention: Of those who agree to colonoscopy or FOBT, the proportion of patients who have colonoscopy scheduled or take home FOBT cards.
Time frame: one year
Preventive Behavior: Of the subjects with a positive FOBT result, determine the proportion adhering to the follow-up colonoscopy.
Time frame: one year
Identification of variables in the survey (based on the Health Belief Model) which are associated with non-adherence to screening.
Time frame: one yearone year, and then annually for two more years
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 12 Jun 2012.
- Derived from this study: PubMed 22493463Inadomi JM, Vijan S, Janz NK, Fagerlin A, Thomas JP, Lin YV, Munoz R, Lau C, Somsouk M, El-Nachef N, Hayward RA. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012 Apr 9;172(7):575-82. doi: 10.1001/archinternmed.2012.332.
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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.
Hal F Yee, MD, PhD 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?
An observational study of Colorectal Cancer Screening, 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 5 inclusion and 5 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 12 Jun 2012. 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?
Adherence to colorectal cancer (CRC) screening, defined as completion of the screening strategy (the subject agrees to pursue/scheduled by the primary care provider). (time frame: one year, and then annually for two more years). 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 NCT00705731, 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 12 Jun 2012.