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

Completed

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

• Registration Number: NCT03906110
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-03
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C-Cares Plus	Personalized One on One Education	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.
C-Cares Plus	Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials	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.
C-Cares	Fecal Immunochemical Test (FIT)	Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.
C-Cares	Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials	Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.
C-Cares	Contact Message	Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.
C-Cares Plus	Contact Message	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.
C-Cares Plus	Fecal Immunochemical Test (FIT)	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.

Primary Outcome Measures

Name	Time	Method
Fecal Immunochemical Test (FIT) Use- Time Point 2	Time Point 2 (up to 18 months)	Participants use of FIT kits will be measured based on FIT sample return rate.
Fecal Immunochemical Test (FIT) use -Time Point 1	Time Point 1 (at 3 months)	Participants use of FIT kits will be measured based on FIT sample return rate.
Fecal Immunochemical Test (FIT) Use- Time Point 3	Time Point 3 (End of study, up to 30 months)	Participants long term FIT adherence will be measured based on FIT sample return rate.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States