NCT04464668

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress79%
Jun 2020Dec 2027

Study Start

First participant enrolled

June 25, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

7.3 years

First QC Date

July 2, 2020

Last Update Submit

December 2, 2025

Conditions

Colorectal Cancer

Keywords

Fecal Immunochemical TestF.I.T.

Outcome Measures

Primary Outcomes (2)

  • Change in Colorectal Cancer Screening Rates - Initial FIT

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

    Years 1-5

  • Change in Colorectal Cancer Screening Rates - Repeat FIT

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

    Years 1-5

Secondary Outcomes (1)

  • Differences in Screening Rates

    Years 2-5

Study Arms (3)

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 ToolsBehavioral: Provider surveys

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 ToolsBehavioral: Provider surveys

Interventions

Provider ToolsBEHAVIORAL

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.

All ClinicsWave 1 Only: Clinics using CARES Intervention
Provider surveysBEHAVIORAL

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)

All ClinicsWave 1 Only: Clinics using CARES Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Pollard J, Friedman M, Byrne MM, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center Clinics: A stepped-wedge, multilevel intervention trial. Contemp Clin Trials. 2026 Mar 2:108274. doi: 10.1016/j.cct.2026.108274. Online ahead of print.

    PMID: 41780746DERIVED

  • Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Joshua A, Pollard J, Friedman M, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center clinics: A stepped-wedge, multilevel intervention trial. Res Sq [Preprint]. 2024 Jul 18:rs.3.rs-4558718. doi: 10.21203/rs.3.rs-4558718/v1.

    PMID: 39070625DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clement K Gwede, PhD MPH RN FAAN

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 9, 2020

Study Start

June 25, 2020

Primary Completion (Estimated)

October 26, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations

US(1)