Colorectal CancerEPICSNCT01805622
Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial
A study testing Active Arm #1, #2, Passive Arm #1, #2 in people with Colorectal Cancer, run by Morehouse School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Active Arm #1, #2, Passive Arm #1, #2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
Selina A. Smith, PhD, MDiv, 404-752-1586, ssmith@msm.edu
Daniel S. Blumenthal, MD, MPH, (404) 752-1625, dblumenthal@msm.edu
About this study
Official title: Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening
- 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Active Arm #1, #2, Passive Arm #1, #2
- Keywords
- community-based participatory research, colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Arm #1, #2, Passive Arm #1, #2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Active Arm #1, #2, Passive Arm #1, #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach (RE-AIM Framework)
The proportion of representative eligible community coalitions and individuals participating in the trial.
Measured: up to 12 months
Effectiveness (RE-AIM Framework)
Post-intervention changes in CRC screening rates.
Measured: up to 24 months
Secondary outcomes (2)
Adoption (RE-AIM Framework)
Percentage of community coalitions implementing the EPICS sessions.
Measured: up to 36 months
Implementation (RE-AIM Framework)
Quality and consistency of the intervention delivery.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Selina A. Smith, Morehouse School of Medicine
- Investigators
- Selina A. Smith, PhD, MDiv, Principal investigator, Morehouse School of MedicineDaniel S. Blumenthal, MD, MPH, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805622
- Sponsor's protocol ID
- EPICS cRCT
- Other IDs
- 1R01CA166785
- Acronym
- EPICS
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2013
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23067354Smith 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.
PubMed 23124502Ansa 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.
PubMed 37790949Smith 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.
PubMed 23924263
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT01805622
- Acronym / sponsor ID
- EPICS / EPICS cRCT
- Conditions
- Colorectal Cancer
- Keywords
- community-based participatory research, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Passive Arm #1 | Experimental | Behavioral: Active Arm #1, #2, Passive Arm #1, #2Active 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. |
| Passive Arm #2 | Experimental | Behavioral: Active Arm #1, #2, Passive Arm #1, #2Active 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 | Active comparator | Behavioral: Active Arm #1, #2, Passive Arm #1, #2Active 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 #2 | Active comparator | Behavioral: Active Arm #1, #2, Passive Arm #1, #2Active 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Arm #1, #2, Passive Arm #1, #2This 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. | Behavioural | Active Arm #1, Active Arm #2, Passive Arm #1, Passive Arm #2 |
Primary outcome
Reach (RE-AIM Framework)
Time frame: up to 12 months
The proportion of representative eligible community coalitions and individuals participating in the trial.
Effectiveness (RE-AIM Framework)
Time frame: up to 24 months
Post-intervention changes in CRC screening rates.
2 secondary outcomes
Adoption (RE-AIM Framework)
Time frame: up to 36 months
Implementation (RE-AIM Framework)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 23067354Smith 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.
- Background: PubMed 23124502Smith 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.
- Derived from this study: PubMed 37790949Ansa 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.
- Derived from this study: PubMed 23924263Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina A. Smith, PhD, MDiv principal investigator
Morehouse School of Medicine
Daniel S. Blumenthal, MD, MPH principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Arm #1, #2, Passive Arm #1, #2 in people with Colorectal Cancer, run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selina A. Smith, PhD, MDiv ((404) 752-1586, ssmith@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (RE-AIM Framework) (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805622, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013; AzTrials last refreshed its copy on 1 Nov 2026.