NCT01904656

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

7.3 years

First QC Date

July 12, 2013

Last Update Submit

April 18, 2022

Conditions

Colon CancerRectal Cancer

Keywords

Colorectal Cancer ScreeningOhio Appalachia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Confounding - Measurement of prognostic factors measured at baseline for evidence of any imbalance

    Up to 2 years

  • Effect Modification

    Up to 3 years

Study Arms (2)

Arm I

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.

Behavioral: "Get Behind your health"

Arm II

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.

Behavioral: Peaches

Interventions

"Get Behind your health"BEHAVIORAL

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 I
PeachesBEHAVIORAL

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.

Arm II

Eligibility Criteria

Age51 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Electra Paskett

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 22, 2013

Study Start

September 1, 2009

Primary Completion

December 31, 2016

Study Completion

April 20, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)