Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)

April 17, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) : A Multilevel Intervention to Increase Colorectal Cancer Screening Adherence In Community Clinics

The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Established patients of community health clinics aged 50-75 with average risk of colorectal cancer.

Description

Inclusion Criteria:

  • Able to understand, read and speak English or Spanish
  • Are not up-to-date with colorectal cancer screening
  • No symptoms of colorectal cancer
  • Not at increased risk for colorectal cancer due to family history or personal high-risk GI syndromes

Exclusion Criteria:

  • Symptoms of colorectal cancer
  • Family history of colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
C-Cares
Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.
Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials
Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.
Behavioral: Contact Message
Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
Diagnostic test: Fecal Immunochemical Test (FIT)
The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
C-Cares Plus
Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) materials, FIT kits, and personalized one-on-one education and coaching.
Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials
Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.
Behavioral: Contact Message
Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
Diagnostic test: Fecal Immunochemical Test (FIT)
The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
Behavioral: Personalized One on One Education
  • Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection.
  • Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT.
  • For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic.
  • Participants will receive a one page summary of key points of salience of repeat screening "GET FIT AGAIN". Another FIT kit is provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fecal Immunochemical Test (FIT) use -Time Point 1
Time Frame: Time Point 1 (at 3 months)
Participants use of FIT kits will be measured based on FIT sample return rate.
Time Point 1 (at 3 months)
Fecal Immunochemical Test (FIT) Use- Time Point 2
Time Frame: Time Point 2 (up to 18 months)
Participants use of FIT kits will be measured based on FIT sample return rate.
Time Point 2 (up to 18 months)
Fecal Immunochemical Test (FIT) Use- Time Point 3
Time Frame: Time Point 3 (End of study, up to 30 months)
Participants long term FIT adherence will be measured based on FIT sample return rate.
Time Point 3 (End of study, up to 30 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Florida Department of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-19106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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