Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

August 13, 2026 updated by: Mark Dignan, PhD

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29772

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 50-74
  • all races, sexes and genders
  • resident of the study area

Exclusion Criteria:

.no exclusions based on gender, race or ethnicity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multi-level Intervention
Receives the project intervention first
Behavioral: Multi-level intervention to increase CRC screening
Intervention for the community, providers, patients, clinics and systems
No Intervention: Delayed Multi-level Intervention
Offered the intervention later in the project

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRC Screening - Clinic Level
Time Frame: Y1 Follow-up
This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Y1 Follow-up
CRC Screening - Clinic Level
Time Frame: Y2 Follow-up
This is the Y2 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Y2 Follow-up
CRC Screening - Clinic Level
Time Frame: Y0 Baseline
This is the baseline clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Y0 Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CRC Screening - Community (County) Level
Time Frame: Y0 Baseline
Weighted estimates of clinic-level CRC screening status (within/not within CRC Screening Guidelines) among adults aged 50-74 were calculated from survey data collected in Pair 2 and Pair 3 counties. Estimates were weighted using balancing weights and county/state-level weighting factors to account for sampling design and oversampling. Reported values are weighted mean estimates with 95% confidence intervals and are not participant-level percentages.
Y0 Baseline
CRC Screening - Community Level
Time Frame: Y2 Follow-up
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Y2 Follow-up
CRC Screening - Community Level
Time Frame: Y1 Follow-up
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Y1 Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mark Dignan, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark B Dignan, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018C0166
  • UH3CA233282 (U.S. NIH Grant/Contract)
  • 832127323 (Other Identifier: DUNS - The Ohio State University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium.

Dataset Items in the LDS are defined by the Common Data Elements.

There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers.

In addition, all data that underlie results in publications will be available per Notice of Award.

IPD Sharing Time Frame

Baseline data available beginning 10/2020, follow-up data available 12/2023

IPD Sharing Access Criteria

There are 2 classes of dataset requests: 1) public use and 2) special. Requestors submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use data set containing common data elements will be made available to external researchers by application. IMS responds to public use dataset application by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must first submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive review by NCI and Research Triangle Institute (RTI) before being forwarded to the SC for review and approval. Requestors report every 6 months on published articles or conference presentations to RTI. Requestors also are encouraged to make articles available through PubMed Central website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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