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

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ClinicalTrials.gov Identifier: NCT04427527
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Ohio State University
Information provided by (Responsible Party):
Mark Dignan, PhD, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Multi-level intervention to increase CRC screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Primary care clinics randomized to intervention or usual care
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Primary care clinics randomized to usual care do not receive intervention materials or attention
Primary Purpose: Screening
Official Title: Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. CRC screening - clinic level [ Time Frame: 12 months ]
    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 :
  1. CRC screening - community level [ Time Frame: 12 months ]
    Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-report of gender
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427527


Contacts
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Contact: Mark B Dignan, PhD 859-323-4708 mark.dignan@uky.edu
Contact: Mark Cromo, BS 859-257-3833 mark.cromo@uky.edu

Locations
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United States, Kentucky
Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Mark Dignan, Ph.D., MPH    859-323-4708    mbdign2@email.uky.edu   
Contact: Mark Cromo, BS    859-257-3833    mark.cromo@uky.edu   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Electra Paskett, PhD    614-293-3917    electra.paskett@osumc.edu   
Contact: Jill Oliveri, DrPH    614-293-8174    jill.oliveri@osumc.edu   
Sponsors and Collaborators
University of Kentucky
National Cancer Institute (NCI)
Ohio State University
Investigators
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Principal Investigator: Mark B Dignan, PhD University of Kentucky
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mark Dignan, PhD, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04427527    
Other Study ID Numbers: 2018C0166
UH3CA233282 ( U.S. NIH Grant/Contract )
832127323 ( Other Identifier: DUNS - The Ohio State University )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases