Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)

Study Overview
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Brief Summary
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The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.

Official Title
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Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project

Conditions
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Colorectal Cancer, Colorectal Carcinoma

Intervention / Treatment
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* Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
* Behavioral: LATINOS CARES Toolkit
* Behavioral: Standard Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 50-75 years Self-identify as Hispanic/Latino Able to understand, read, and speak Spanish Prefer to receive health information in Spanish Previously screened or not screened

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LATINOS CARES Toolkit<br>Participants assigned to the LATINOS CARES condition will receive an I-FOBT kit, DVD and photonovella booklet from the study coordinator. The participant will view the DVD in a private area (headphones are available) using a portable DVD player in clinic before seeing the provider. The DVD will be about 8-10 minutes long. The participant will take the LATINOS CARES toolkit and I-FOBT home after the clinic visit. The participant will be instructed to re-review the materials and complete the I-FOBT stool sampling at home. | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit<br>* Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.<br>Behavioral: LATINOS CARES Toolkit<br>* DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.<br>|
| Active Comparator: Standard Intervention (SI)<br>Participants assigned to the standard brochure (SI) will be provided a packet containing the CDC Spanish-language tri-fold brochure titled Screen for Life and an I-FOBT card. The participant will be instructed to review the materials in clinic and complete the I-FOBT stool sampling at home. This brochure describes CRC, risk factors, symptoms, screening tests, benefits of screening, and insurance coverage. | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit<br>* Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.<br>Behavioral: Standard Intervention<br>* Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Feedback from Community Advisory Board | Successful collection of feedback to complete production of Spanish-language LATINOS CARES Intervention. This aim involves no statistical analysis except the summary statistics for the participants. To adapt (transcreate) and produce an educational intervention entitled LATINOS CARES (DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. BENCHMARK: Production of Spanish-language LATINOS CARES intervention that is easy-to understand, salient, and culturally suitable. | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Receipt of I-FOBT from Participants | BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit). | Up to 4 months | 
| Rate of Receipt of Assessments from Participants | BENCHMARK: Receipt of Assessments. | Up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer screening, colon