Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

NCT ID: NCT01805622

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-03-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Arm #1, #2, Passive Arm #1, #2

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Active Arm #1, #2, Passive Arm #1, #2

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Active Arm #1, #2, Passive Arm #1, #2

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Active Arm #1, #2, Passive Arm #1, #2

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Selina A. Smith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selina A. Smith, PhD, MDiv

Role: PRINCIPAL_INVESTIGATOR

Morehouse School of Medicine

Daniel S. Blumenthal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Morehouse School of Medicine

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Selina A. Smith, PhD, MDiv

Role: CONTACT

ssmith@msm.edu

(404) 752-1586

Daniel S. Blumenthal, MD, MPH

Role: CONTACT

sblumenthal@msm.edu

(404) 752-1625

Facility Contacts

Selina A. Smith, PhD, MDiv

Role: primary

ssmith@msm.edu

404-752-1586

Daniel S. Blumenthal, MD, MPH

Role: backup

dblumenthal@msm.edu

(404) 752-1625

References

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.

Reference Type: BACKGROUND

PMID: 23067354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23124502 (View on PubMed)

Ansa BE, Alema-Mensah E, Sheats JQ, Mubasher M, Akintobi TH. Colorectal Cancer Knowledge and Screening Change in African Americans: Implementation Phase Results of the EPICS Cluster RCT. AJPM Focus. 2023 Jun 13;2(4):100121. doi: 10.1016/j.focus.2023.100121. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 37790949 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23924263 (View on PubMed)

Other Identifiers

1R01CA166785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EPICS cRCT

Identifier Type: -

Identifier Source: org_study_id