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CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

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ClinicalTrials.gov Identifier: NCT01904656
Recruitment Status : Active, not recruiting
First Posted : July 22, 2013
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center

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

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Behavioral: "Get Behind your health" Behavioral: Peaches Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community-Based Participatory Research(CBPR)Strategies in Increasing Colorectal Cancer(CRC)Screening in Participants in Ohio Appalachia
Study Start Date : September 2009
Actual Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Confounding - Measurement of prognostic factors measured at baseline for evidence of any imbalance [ Time Frame: Up to 2 years ]
    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.

  2. Effect Modification [ Time Frame: Up to 3 years ]
    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+).



Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904656


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Electra Paskett Ohio State University
Additional Information:
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Responsible Party: Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01904656    
Other Study ID Numbers: OSU-08168
NCI-2012-00605 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R24MD002785 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Electra Paskett, Ohio State University Comprehensive Cancer Center:
Colorectal Cancer Screening
Ohio Appalachia
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases