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Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health (CARES-REACH)

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ClinicalTrials.gov Identifier: NCT04464668
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.

Condition or disease Intervention/treatment
Colorectal Cancer Behavioral: Provider Tools Behavioral: Provider interviews

Detailed Description:
This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : January 28, 2024
Estimated Study Completion Date : January 28, 2025

Group/Cohort Intervention/treatment
Wave 1 Only: Clinics using CARES Intervention
Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education & Screening (CARES) intervention.
Behavioral: Provider Tools
Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.

Behavioral: Provider interviews
Semi-structured interviews will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)

Wave 1 Only: Control Clinics
Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics.
All Clinics
For Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2.
Behavioral: Provider Tools
Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.

Behavioral: Provider interviews
Semi-structured interviews will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)




Primary Outcome Measures :
  1. Change in Colorectal Cancer Screening Rates - Initial FIT [ Time Frame: Years 1-5 ]
    Percentage of patients who complete initial Fecal Immunochemical Test (FIT)

  2. Change in Colorectal Cancer Screening Rates - Repeat FIT [ Time Frame: Years 1-5 ]
    Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)


Secondary Outcome Measures :
  1. Differences in Screening Rates [ Time Frame: Years 2-5 ]
    Screening rate differences to determine how variables such as clinic setting (rural vs urban), population characteristics such as nativity (foreign born status), language preference, education, income, health insurance, etc. differentially impact annual clinic Colorectal Cancer (CRC) screening rates.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.
Criteria

Inclusion Criteria:

  • Staff and providers working in a clinic within one of the two participating systems
  • Involved in adult patient care

Exclusion Criteria:

  • Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening

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): NCT04464668


Contacts
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Contact: K

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Rania Abdulla, MA    813-745-6813    Rania.Abdulla@moffitt.org   
Principal Investigator: Clement K Gwede, PhD MPH RN         
Sub-Investigator: Margaret Byrne, PhD         
Sub-Investigator: Shannon Christy, PhD         
Sub-Investigator: Mark S Friedman, MD         
Sub-Investigator: Cathy D Meade, PhD, RN         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clement K Gwede, PhD MPH RN FAAN Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04464668    
Other Study ID Numbers: MCC-20560
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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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
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Fecal Immunochemical Test
F.I.T.
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