Clinical trial NCT01805622: Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial
Official title: Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: community-based participatory research
colorectal cancer screening
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-06
Enrollment: 7200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Reach (RE-AIM Framework)
timeFrame: up to 12 months
measure: Effectiveness (RE-AIM Framework)
timeFrame: up to 24 months
Secondary outcomes:
measure: Adoption (RE-AIM Framework)
timeFrame: up to 36 months
measure: Implementation (RE-AIM Framework)
timeFrame: up to 36 months
Other outcomes:
measure: Maintenance (RE-AIM Framework)
timeFrame: up to 24 months
measure: Cost-effectiveness analysis
timeFrame: up to 60 months
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
Study officials:
affiliation: Morehouse School of Medicine
name: Selina A. Smith, PhD, MDiv
role: PRINCIPAL_INVESTIGATOR
affiliation: Morehouse School of Medicine
name: Daniel S. Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.