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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04464668
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 32
• Location: 1
• Anticipated Duration (Months): 55.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Provider Tools; Behavioral: Provider surveys

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.

Study Design

• Study Type: Observational
• Anticipated 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: Jun 25, 2020
• Anticipated Primary Completion Date: Jan 28, 2024
• Anticipated Study Completion Date: Jan 28, 2025

Arms and Interventions

Arm	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 surveys; Remote/electronic data collection surveys 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 surveys; Remote/electronic data collection surveys 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)

Outcome Measures

Primary Outcome Measures

1. Change in Colorectal Cancer Screening Rates - Initial FIT [Years 1-5]

   Percentage of patients who complete initial Fecal Immunochemical Test (FIT)

2. Change in Colorectal Cancer Screening Rates - Repeat FIT [Years 1-5]

   Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)

Secondary Outcome Measures

1. Differences in Screening Rates [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Clement K Gwede, PhD MPH RN FAAN, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT04464668
• Other Study ID Numbers: MCC-20560
• First Posted: Jul 9, 2020
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• 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: Colorectal Neoplasms

Study Results

No Results Posted as of Aug 22, 2022