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


N/A
50 Years
74 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Reach (RE-AIM Framework)

Outcome Description:

The proportion of representative eligible community coalitions and individuals participating in the trial.

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Selina A. Smith, PhD, MDiv

Investigator Role:

Principal Investigator

Investigator Affiliation:

Morehouse School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

EPICS cRCT

NCT ID:

NCT01805622

Start Date:

August 2012

Completion Date:

March 2017

Related Keywords:

  • Colorectal Cancer
  • community-based participatory research
  • colorectal cancer screening
  • Colorectal Neoplasms

Name

Location

Morehouse School of MedicineAtlanta, Georgia  30310-1495