NCT01805622

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,200

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

4.6 years

First QC Date

March 1, 2013

Last Update Submit

March 4, 2013

Conditions

Colorectal Cancer

Keywords

community-based participatory researchcolorectal cancer screening

Outcome Measures

Primary Outcomes (2)

  • Reach (RE-AIM Framework)

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

    up to 12 months

  • Effectiveness (RE-AIM Framework)

    Post-intervention changes in CRC screening rates.

    up to 24 months

Secondary Outcomes (2)

  • Adoption (RE-AIM Framework)

    up to 36 months

  • Implementation (RE-AIM Framework)

    up to 36 months

Other Outcomes (2)

  • Maintenance (RE-AIM Framework)

    up to 24 months

  • Cost-effectiveness analysis

    up to 60 months

Study Arms (4)

Passive Arm #1

EXPERIMENTAL

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.

Behavioral: Active Arm #1, #2, Passive Arm #1, #2

Passive Arm #2

EXPERIMENTAL

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.

Behavioral: Active Arm #1, #2, Passive Arm #1, #2

Active Arm #1

ACTIVE COMPARATOR

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.

Behavioral: Active Arm #1, #2, Passive Arm #1, #2

Active Arm #2

ACTIVE COMPARATOR

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.

Behavioral: Active Arm #1, #2, Passive Arm #1, #2

Interventions

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

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

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23067354BACKGROUND

  • 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.

    PMID: 23124502BACKGROUND

  • 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.

    PMID: 37790949DERIVED

  • 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.

    PMID: 23924263DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Selina A. Smith, PhD, MDiv

    Morehouse School of Medicine

    PRINCIPAL INVESTIGATOR

  • Daniel S. Blumenthal, MD, MPH

    Morehouse School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina A. Smith, PhD, MDiv

CONTACT

(404) 752-1586ssmith@msm.edu

Daniel S. Blumenthal, MD, MPH

CONTACT

(404) 752-1625sblumenthal@msm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 6, 2013

Study Start

August 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

US(1)