Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Active Arm #1, #2, Passive Arm #1, #2

• Registration Number: NCT01805622
• Lead Sponsor: Morehouse School of Medicine

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.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-03
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-04
• Last Update Submitted: 2013-03-04
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive Arm #1	Active Arm #1, #2, Passive Arm #1, #2	Active Arm #1, 2; Passive Arm #1, 2 Community coalitions randomized to the Passive Arm #1-Web Access Without Technical Assistance will receive access to EPICS facilitator training materials and toolkits via the Research-Tested Intervention Programs (RTIPs) website and will not participate in monthly technical assistance teleconferences.
Passive Arm #2	Active Arm #1, #2, Passive Arm #1, #2	Active Arm #1, #2; Passive Arm #1, #2 Community coalitions randomized to the Passive Arm #2-Web Access With Technical Assistance will receive access to EPICS facilitator training materials and toolkits via the Research-Tested Intervention Programs (RTIPs) website and will participate in monthly technical assistance teleconferences.
Active Arm #1	Active Arm #1, #2, Passive Arm #1, #2	Active Arm #1, #2; Passive Arm #1, #2 Community coalitions randomized to Active Arm #1-In-Person Access Without Technical Assistance will receive training from intervention developers with access to facilitator training materials but will not participate in monthly technical assistance teleconferences.
Active Arm #2	Active Arm #1, #2, Passive Arm #1, #2	Active Arm #1, #2; Passive Arm #1, #2 Community coalitions randomized to Active Arm #2-In-Person Access with Technical Assistance will receive training from intervention developers with access to facilitator training materials and will participate in monthly technical assistance teleconferences.

Primary Outcome Measures

Name	Time	Method
Reach (RE-AIM Framework)	up to 12 months	The proportion of representative eligible community coalitions and individuals participating in the trial.
Effectiveness (RE-AIM Framework)	up to 24 months	Post-intervention changes in CRC screening rates.

Secondary Outcome Measures

Name	Time	Method
Adoption (RE-AIM Framework)	up to 36 months	Percentage of community coalitions implementing the EPICS sessions.
Implementation (RE-AIM Framework)	up to 36 months	Quality and consistency of the intervention delivery.

Trial Locations

Locations (1)

Morehouse School of Medicine; 🇺🇸 Atlanta, Georgia, United States