Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

Colorectal Cancer Clinical Trial

— EPICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01805622
• Other study ID #: EPICS cRCT
• Secondary ID: 1R01CA166785
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2013
• Last updated: March 4, 2013
• Start date: August 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2013
• Source: Morehouse School of Medicine
• Contact: Selina A. Smith, PhD, MDiv
• Phone: (404) 752-1586
• Email: ssmith[@]msm.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7200
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Morehouse School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Morehouse School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance (RE-AIM Framework)	The extent to which community coalitions continue to implement EPICS post-implementation.	up to 24 months	No
Other	Cost-effectiveness analysis	Compare passive to active dissemination costs.	up to 60 months	No
Primary	Reach (RE-AIM Framework)	The proportion of representative eligible community coalitions and individuals participating in the trial.	up to 12 months	No
Primary	Effectiveness (RE-AIM Framework)	Post-intervention changes in CRC screening rates.	up to 24 months	No
Secondary	Adoption (RE-AIM Framework)	Percentage of community coalitions implementing the EPICS sessions.	up to 36 months	No
Secondary	Implementation (RE-AIM Framework)	Quality and consistency of the intervention delivery.	up to 36 months	No