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Clinical Trials/NCT01904656
NCT01904656
Completed
N/A

Community-Based Participatory Research(CBPR)Strategies in Increasing Colorectal Cancer(CRC)Screening in Participants in Ohio Appalachia

Ohio State University Comprehensive Cancer Center1 site in 1 country4,509 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colon Cancer
Sponsor
Ohio State University Comprehensive Cancer Center
Enrollment
4509
Locations
1
Primary Endpoint
Rates of colorectal cancer screening-within-guidelines (status obtained by medical record review).
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

PRIMARY OBJECTIVES: I. Utilize CBPR methods to develop specific county-level media campaigns and a clinic-based chart reminder for 12 Ohio Appalachia counties focused on CRC screening or an attention control message. II. Implement and test, using a group-randomized design, a staggered county-wide intervention program that consists of county-specific media campaigns, clinic-specific chart reminder systems, and a combination of both strategies in 6 randomly selected intervention counties vs. an attention control condition in 6 randomly selected control counties. III. Utilize process and outcome evaluation strategies to assess the efficacy of each strategy. IV. Utilize the results to plan the dissemination of the intervention into 36 Appalachian counties in 6 additional states of the Appalachia Community Cancer Network (ACCN) in a subsequent study. OUTLINE: Participants are randomized to 1 of 2 arms. Arm I: Participants are exposed to the "Get Behind Your Health!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4. Arm II: Participants are exposed to a media campaign, patient education material in clinics, and a combination related to healthy eating, "PEACHES" (Promoting Education in Appalachia on Cancer and Healthy Eating Styles). Participants also undergo telephone interviews during years 2-4.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
April 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Electra Paskett

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Rates of colorectal cancer screening-within-guidelines (status obtained by medical record review).

Time Frame: Up to 4 years

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.

Secondary Outcomes

  • Confounding - Measurement of prognostic factors measured at baseline for evidence of any imbalance(Up to 2 years)
  • Effect Modification(Up to 3 years)

Study Sites (1)

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