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

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: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials; Behavioral: Contact Message; Diagnostic test: Fecal Immunochemical Test (FIT); Behavioral: Personalized One on One Education

• Study Type: Observational
• Enrollment (Actual): 327

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Fecal Immunochemical Test (FIT) use -Time Point 1	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	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	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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Florida Department of Health

Publications and helpful links

General Publications

• Christy SM, Sutton SK, Abdulla R, Boxtha C, Gonzalez P, Cousin L, Ewing A, Montoya S, Lopez D, Beehler T, Sanchez J, Carvajal R, Meade CD, Gwede CK. A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial. Prev Med. 2022 May;158:107021. doi: 10.1016/j.ypmed.2022.107021. Epub 2022 Mar 17.

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal Cancer Screening; Fecal Immunochemical Test; FIT test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID 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