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Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01805622
Acronym
EPICS
Enrollment
7200
Registered
2013-03-06
Start date
2012-08-31
Completion date
2017-03-31
Last updated
2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

community-based participatory research, colorectal cancer screening

Brief summary

* Hypothesis 1. When compared to passive dissemination, active dissemination will result in greater participant enrollment. * Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics and community sites. * Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively correlated.

Detailed description

In this study, investigators aim to evaluate 20 community coalitions and 7,200 participants by: testing passive and active approaches to disseminating the Educational Program to Increase Colorectal Cancer Screening (EPICS) to increase screening rates for colorectal cancer; measuring the extent to which EPICS is accepted and the fidelity of implementation in various settings and estimating the potential translatability and public health impact of EPICS. This four-arm cluster randomized trial (five community coalitions plus 1,800 African Americans, 50-74 years of age, who are not current on colorectal cancer (CRC) screening per arm) compares the following implementation strategies: (1) web access to facilitator training materials and toolkits without technical assistance (TA); (2) web access, but with technical assistance (TA); (3) in-person access to facilitator training materials and toolkits without TA and (4) in-person access with TA. Primary outcome measures are the reach (the proportion of representative eligible community coalitions and individuals participating in the trial) and effectiveness (post-intervention changes in CRC screening rates). Secondary outcomes include adoption (percentage of community coalitions implementing the EPICS sessions) and implementation (quality and consistency of the intervention delivery). The extent to which community coalitions continue to implement EPICS post-implementation (maintenance) will also be measured. Cost-effectiveness analysis will be conducted to compare passive to active dissemination costs. Investigators believe that implementing this evidence-based colorectal cancer screening intervention in partnership with community coalitions will result in more rapid adoption than traditional top-down approaches, and that changes in community CRC screening practices are more likely to be sustainable over time. With its national reach, this study has the potential to enhance understanding of barriers and enablers to the uptake of educational programs aimed at eliminating cancer health disparities.

Interventions

BEHAVIORALActive Arm #1, #2, Passive Arm #1, #2

This four-arm cluster randomized trial (five community coalitions plus 1,800 African Americans, 50-74 years of age, who are not current on CRC screening per arm) compares the following implementation strategies: (1) web access to facilitator training materials and toolkits without technical assistance (TA); (2) web access, but with technical assistance (TA); (3) in-person access to facilitator training materials and toolkits without TA and (4) in-person access with TA.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Morehouse School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation

Exclusion criteria

* Individuals with a personal history of CRC or inflammatory bowel disease, blindness or severe hearing impairment; dementia; or other condition with life expectancy less than two years, are ineligible for participation

Design outcomes

Primary

MeasureTime frameDescription
Reach (RE-AIM Framework)up to 12 monthsThe proportion of representative eligible community coalitions and individuals participating in the trial.
Effectiveness (RE-AIM Framework)up to 24 monthsPost-intervention changes in CRC screening rates.

Secondary

MeasureTime frameDescription
Adoption (RE-AIM Framework)up to 36 monthsPercentage of community coalitions implementing the EPICS sessions.
Implementation (RE-AIM Framework)up to 36 monthsQuality and consistency of the intervention delivery.

Other

MeasureTime frameDescription
Maintenance (RE-AIM Framework)up to 24 monthsThe extent to which community coalitions continue to implement EPICS post-implementation.
Cost-effectiveness analysisup to 60 monthsCompare passive to active dissemination costs.

Countries

United States

Contacts

Primary ContactSelina A. Smith, PhD, MDiv
ssmith@msm.edu(404) 752-1586
Backup ContactDaniel S. Blumenthal, MD, MPH
sblumenthal@msm.edu(404) 752-1625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026