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

NCT ID: NCT04464668

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-25

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Provider Tools

Intervention Type BEHAVIORAL

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.

Provider surveys

Intervention Type BEHAVIORAL

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.

No interventions assigned to this group

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.

Provider Tools

Intervention Type BEHAVIORAL

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.

Provider surveys

Intervention Type BEHAVIORAL

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clement K Gwede, PhD MPH RN FAAN

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39070625 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-20560

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.