NCT04427527

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,413

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

4.6 years

First QC Date

June 3, 2020

Last Update Submit

October 9, 2025

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • CRC screening - clinic level

    Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data

    12 months

Secondary Outcomes (1)

  • CRC screening - community level

    12 months

Study Arms (2)

Multi-level Intervention

EXPERIMENTAL

Receives the project intervention first

Behavioral: Multi-level intervention to increase CRC screening

Delayed Multi-level Intervention

NO INTERVENTION

Offered the intervention later in the project

Interventions

Multi-level intervention to increase CRC screeningBEHAVIORAL

Intervention for the community, providers, patients, clinics and systems

Multi-level Intervention

Eligibility Criteria

Age50 Years - 74 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-report of gender
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Paskett ED, Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Gray DM, Pennell ML, Huang B, Young GS, Fickle D, Cromo M, Katz ML, Reiter PL, Rogers M, Gross DA, Fairchild V, Xu W, Carman A, Walunis JM, McAlearney AS, Huerta TR, Rahurkar S, Biederman E, Dignan M. Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial. Transl Behav Med. 2023 Sep 28;13(10):748-756. doi: 10.1093/tbm/ibad017.

    PMID: 37202831DERIVED

  • Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8.

    PMID: 34011410DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark B Dignan, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Primary care clinics randomized to usual care do not receive intervention materials or attention
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: Primary care clinics randomized to intervention or usual care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 11, 2020

Study Start

August 19, 2020

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Baseline data available beginning 10/2020, follow-up data available 12/2023
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.

Locations

US(2)