search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-level intervention to increase CRC screening
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Markey Cancer CenterRecruiting
  • Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multi-level Intervention

Delayed Multi-level Intervention

Arm Description

Receives the project intervention first

Offered the intervention later in the project

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CRC screening - community level
Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys

Full Information

First Posted
June 3, 2020
Last Updated
June 6, 2023
Sponsor
University of Kentucky
Collaborators
National Cancer Institute (NCI), Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT04427527
Brief Title
Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia
Acronym
ACCSIS
Official Title
Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
Collaborators
National Cancer Institute (NCI), Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Primary care clinics randomized to intervention or usual care
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Primary care clinics randomized to usual care do not receive intervention materials or attention
Allocation
Randomized
Enrollment
6240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-level Intervention
Arm Type
Experimental
Arm Description
Receives the project intervention first
Arm Title
Delayed Multi-level Intervention
Arm Type
No Intervention
Arm Description
Offered the intervention later in the project
Intervention Type
Behavioral
Intervention Name(s)
Multi-level intervention to increase CRC screening
Intervention Description
Intervention for the community, providers, patients, clinics and systems
Primary Outcome Measure Information:
Title
CRC screening - clinic level
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CRC screening - community level
Description
Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-report of gender
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark B Dignan, PhD
Phone
859-323-4708
Email
mark.dignan@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Cromo, BS
Phone
859-257-3833
Email
mark.cromo@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark B Dignan, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Dignan, Ph.D., MPH
Phone
859-323-4708
Email
mbdign2@email.uky.edu
First Name & Middle Initial & Last Name & Degree
Mark Cromo, BS
Phone
859-257-3833
Email
mark.cromo@uky.edu
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Electra Paskett, PhD
Phone
614-293-3917
Email
electra.paskett@osumc.edu
First Name & Middle Initial & Last Name & Degree
Jill Oliveri, DrPH
Phone
614-293-8174
Email
jill.oliveri@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34011410
Citation
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.
Results Reference
derived

Learn more about this trial

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

We'll reach out to this number within 24 hrs