Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial (EPICS)

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

• 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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Active Arm #1, #2, Passive Arm #1, #2

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 Type: Interventional
• Enrollment (Anticipated): 7200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selina A. Smith, PhD, MDiv; Phone Number: (404) 752-1586; Email: ssmith@msm.edu
• Study Contact Backup: Name: Daniel S. Blumenthal, MD, MPH; Phone Number: (404) 752-1625; Email: sblumenthal@msm.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Recruiting
      • Morehouse School of Medicine
      • Contact: Selina A. Smith, PhD, MDiv; Phone Number: 404-752-1586; Email: ssmith@msm.edu
      • Contact: Daniel S. Blumenthal, MD, MPH; Phone Number: (404) 752-1625; Email: dblumenthal@msm.edu
      • Principal Investigator: Selina A. Smith, PhD, MDiv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Passive Arm #1; 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.	Behavioral: Active 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.
EXPERIMENTAL: Passive Arm #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.	Behavioral: Active 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.
ACTIVE_COMPARATOR: Active Arm #1; 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.	Behavioral: Active 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.
ACTIVE_COMPARATOR: Active Arm #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.	Behavioral: Active 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance (RE-AIM Framework)	The extent to which community coalitions continue to implement EPICS post-implementation.	up to 24 months
Cost-effectiveness analysis	Compare passive to active dissemination costs.	up to 60 months

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Selina A. Smith, PhD, MDiv, Morehouse School of Medicine; Principal Investigator: Daniel S. Blumenthal, MD, MPH, Morehouse School of Medicine

Publications and helpful links

General Publications

• Smith S, Johnson L, Wesley D, Turner KB, McCray G, Sheats J, Blumenthal D. Translation to practice of an intervention to promote colorectal cancer screening among African Americans. Clin Transl Sci. 2012 Oct;5(5):412-5. doi: 10.1111/j.1752-8062.2012.00439.x. Epub 2012 Aug 7.
• Smith SA, Blumenthal DS. Community health workers support community-based participatory research ethics: lessons learned along the research-to-practice-to-community continuum. J Health Care Poor Underserved. 2012 Nov;23(4 Suppl):77-87. doi: 10.1353/hpu.2012.0156.
• Smith SA, Blumenthal DS. Efficacy to effectiveness transition of an Educational Program to Increase Colorectal Cancer Screening (EPICS): study protocol of a cluster randomized controlled trial. Implement Sci. 2013 Aug 7;8:86. doi: 10.1186/1748-5908-8-86.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (ESTIMATE): March 6, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2013
• Last Update Submitted That Met QC Criteria: March 4, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: community-based participatory research; colorectal cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EPICS cRCT; 1R01CA166785 (NIH)