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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C-Cares<br>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<br>* 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.<br>Behavioral: Contact Message<br>* Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.<br>Diagnostic Test: Fecal Immunochemical Test (FIT)<br>* The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.<br>|
| C-Cares Plus<br>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<br>* 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.<br>Behavioral: Contact Message<br>* Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.<br>Behavioral: Personalized One on One Education<br>* 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.<br>Diagnostic Test: Fecal Immunochemical Test (FIT)<br>* The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer Screening, FIT test, Fecal Immunochemical Test