CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

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

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

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: "Get Behind your health"; Behavioral: Peaches

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.

• Study Type: Interventional
• Enrollment (Actual): 4509
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: "Get Behind your health"; 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.
ACTIVE_COMPARATOR: Arm II; Participants are exposed to a Healthy Eating "Peaches!"- 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.	Behavioral: Peaches; Participants are exposed to a "Healthy Eating!" 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Electra Paskett, Ohio State University

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): April 20, 2021

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (ESTIMATE): July 22, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer Screening; Ohio Appalachia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: OSU-08168; NCI-2012-00605 (REGISTRY: CTRP (Clinical Trial Reporting Program)); R24MD002785 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO