Overview

This trial is active, not recruiting.

Conditions colon cancer, rectal cancer
Treatments "get behind your health", peaches
Sponsor Ohio State University Comprehensive Cancer Center
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date September 2009
End date December 2014
Trial size 4320 participants
Trial identifier NCT01904656, NCI-2012-00605, OSU-08168, R24MD002785

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
"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)
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.
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 Outcomes

Measure
Rates of colorectal cancer screening-within-guidelines (status obtained by medical record review).
time frame: Up to 4 years

Secondary Outcomes

Measure
Confounding - Measurement of prognostic factors measured at baseline for evidence of any imbalance
time frame: Up to 2 years
Effect Modification
time frame: Up to 3 years

Eligibility Criteria

Male or female participants from 51 years up to 75 years old.

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)

Additional Information

Official title Community-Based Participatory Research(CBPR)Strategies in Increasing Colorectal Cancer(CRC)Screening in Participants in Ohio Appalachia
Principal investigator Electra Paskett
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.