Rectal Cancer Clinical Trial
Official title:
Community-Based Participatory Research(CBPR)Strategies in Increasing Colorectal Cancer(CRC)Screening in Participants in Ohio Appalachia
Verified date | April 2022 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this project is to implement and evaluate an intervention to increase and sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based participatory research (CBPR) in combination with two CRC interventions that have been developed and piloted with community partners to improve CRC screening
Status | Completed |
Enrollment | 4509 |
Est. completion date | April 20, 2021 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 51 Years to 75 Years |
Eligibility | Inclusion Criteria: - Have a working phone number - Resident of one of the 12 study counties - Lived in that study county since the start of the project - No prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease) - Not currently pregnant - Be in good health (i.e., no contraindications to CRC screening) Exclusion Criteria: - No working phone number - Not a resident of one of the 12 study counties - Does not live in the study county since the start of the project - Has a prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease) - Is currently pregnant - Not in good health(i.e.has contraindications for CRC screening) |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of colorectal cancer screening-within-guidelines (status obtained by medical record review). | The primary research question is whether the intervention will affect the rate of CRC screening-within-guidelines among age-eligible residents in the participating counties. The primary outcome is CRC screening-within-guidelines status defined as having any one of the following: 1) FOBT in the past year; 2) flexible sigmoidoscopy in the past 5 years; 3) FOBT annually + flexible sigmoidoscopy in the past 5 years; 4) double-contrast barium enema in the past 5 years; or 5) colonoscopy in the past 10 years. | Up to 4 years | |
Secondary | Confounding - Measurement of prognostic factors measured at baseline for evidence of any imbalance | Though randomization of 12 counties to each condition from within strata reduces the likelihood that there will be any imbalance in important prognostic factors between the two conditions, confounding remains a possibility in any single realization of an experiment. Left alone, such imbalance could confound the true relationship between condition and the outcomes. To avoid this problem, we will examine prognostic factors measured at baseline for evidence of any imbalance; if it is present, we will perform secondary analyses in which we repeat the primary analysis adding the potential confounders as additional covariates, attending carefully to issues of measurement error which can create problems for such adjustments. Regression adjustment cannot completely correct for confounding, but to the extent that the confounders are well measured and properly modeled, the adjusted analysis will reduce the confounding. | Up to 2 years | |
Secondary | Effect Modification | Other secondary analyses will explore the assumption of homogeneity of the intervention effect across subgroups of participants. Though power will be limited for interactions, we will add subgroup main effects and interactions in order to explore possible effect modification. The primary subgroup variables will be gender and age group (age 55-64 vs. age 65+). | Up to 3 years |
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