Colon Cancer Clinical Trial
— EPIC-DOfficial title:
Improving Appropriate Colorectal Cancer Screening in Elderly Patients
Verified date | May 2015 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.
Status | Completed |
Enrollment | 424 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years to 84 Years |
Eligibility | Inclusion Criteria: - Men and women ages 70 to 84 - Not up to date with colon cancer screening or surveillance Exclusion Criteria: - Men and women younger than 70 years of age or older than 84 - History of Colorectal Cancer - Inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
United States | Duke Practiced Based Research Network | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Agency for Healthcare Research and Quality (AHRQ), Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Appropriate colorectal cancer screening | The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered. | Six months after intervention or control was adminstered | |
Secondary | Appropriate colorectal cancer screening decisions | The proportion of participants classified as having appropriate colorectal cancer screening decisions in the intervention group will be compared to the control group. Appropriate screening decision making is a combined outcome measure using patient report of intent to complete or not complete CRC screening tests and discussions about CRC screening with their provider. This outcome will be measured immediately after the patient and provider index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered. | At baseline (after intervention or control was administered) | |
Secondary | Appropriate screening and mediators | For the mediation analysis covariates will be evaluated as potential mediators. The potential mediators to be examined include adequate preparation for individualized decision making (adequate knowledge+ clear values); knowledge scores, screening preference before the index visit, decisional balance, reported discussion during the index visit, gender, previous screening, functional status, and literacy level. | Six months after intervention or control was adminstered | |
Secondary | Appropriate screening for health strata | Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating exploratory analyses to examine effect of the intervention in sub-groups of patients. We will examine the effect in the three strata (best, intermediate, worst health groups) defined by age and Charlson comorbidity score. | Six months after intervention or control was adminstered | |
Secondary | Appropriate screening for stool cards | For this analysis, appropriate screening test completion will include stool cards for all age groups and health groups. Analyses described for the primary outcome will be performed using this classification of appropriate screening test completion. | Six months after intervention or control was adminstered |
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