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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Arm #1, #2, Passive Arm #1, #2
Sponsored by
Morehouse School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring community-based participatory research, colorectal cancer screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Morehouse School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Passive Arm #1

Passive Arm #2

Active Arm #1

Active Arm #2

Arm Description

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.

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, #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 #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.

Outcomes

Primary Outcome Measures

Reach (RE-AIM Framework)
The proportion of representative eligible community coalitions and individuals participating in the trial.
Effectiveness (RE-AIM Framework)
Post-intervention changes in CRC screening rates.

Secondary Outcome Measures

Adoption (RE-AIM Framework)
Percentage of community coalitions implementing the EPICS sessions.
Implementation (RE-AIM Framework)
Quality and consistency of the intervention delivery.

Full Information

First Posted
March 1, 2013
Last Updated
March 4, 2013
Sponsor
Morehouse School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01805622
Brief Title
Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial
Acronym
EPICS
Official Title
Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Morehouse School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
community-based participatory research, colorectal cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passive Arm #1
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive Arm #2
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Arm #1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Arm #2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Arm #1, #2, Passive Arm #1, #2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reach (RE-AIM Framework)
Description
The proportion of representative eligible community coalitions and individuals participating in the trial.
Time Frame
up to 12 months
Title
Effectiveness (RE-AIM Framework)
Description
Post-intervention changes in CRC screening rates.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Adoption (RE-AIM Framework)
Description
Percentage of community coalitions implementing the EPICS sessions.
Time Frame
up to 36 months
Title
Implementation (RE-AIM Framework)
Description
Quality and consistency of the intervention delivery.
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
Maintenance (RE-AIM Framework)
Description
The extent to which community coalitions continue to implement EPICS post-implementation.
Time Frame
up to 24 months
Title
Cost-effectiveness analysis
Description
Compare passive to active dissemination costs.
Time Frame
up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selina A. Smith, PhD, MDiv
Phone
(404) 752-1586
Email
ssmith@msm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel S. Blumenthal, MD, MPH
Phone
(404) 752-1625
Email
sblumenthal@msm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selina A. Smith, PhD, MDiv
Organizational Affiliation
Morehouse School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel S. Blumenthal, MD, MPH
Organizational Affiliation
Morehouse School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morehouse School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selina A. Smith, PhD, MDiv
Phone
404-752-1586
Email
ssmith@msm.edu
First Name & Middle Initial & Last Name & Degree
Daniel S. Blumenthal, MD, MPH
Phone
(404) 752-1625
Email
dblumenthal@msm.edu
First Name & Middle Initial & Last Name & Degree
Selina A. Smith, PhD, MDiv

12. IPD Sharing Statement

Citations:
PubMed Identifier
23067354
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.
Results Reference
background
PubMed Identifier
23124502
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.
Results Reference
background
PubMed Identifier
23924263
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.
Results Reference
derived

Learn more about this trial

Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

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