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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00705731 |
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Date of registration:
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24/06/2008 |
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Primary sponsor: |
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Public title:
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Adherence and the Economics of Colon Cancer Screening
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Scientific title:
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Adherence and the Economics of Colon Cancer Screening |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00705731 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Hal F Yee, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Age minimum:
50 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer Screening
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Preventive Behavior: Of the subjects with a positive FOBT result, determine the proportion adhering to the follow-up colonoscopy.
[Time Frame: one year]
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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]
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Secondary ID(s)
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3R01CA106773-04S1
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A105658
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K24DK080941
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R01CA106773
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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