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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078361
• Other study ID #: MCC-17665
• Status: Completed
• Phase: N/A
• Start date: April 28, 2014
• Est. completion date: October 26, 2022

Study information

• Verified date: August 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 26, 2022
• Est. primary completion date: July 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
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.

Behavioral:
• LATINOS CARES Toolkit
DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.
• Standard Intervention
Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Bankhead-Coley Cancer Research Program, Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Receipt of I-FOBT from Participants	BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).	Up to 4 months
Secondary	Rate of Receipt of Assessments from Participants	BENCHMARK: Receipt of Assessments.	Up to 4 months

External Links

•   Moffitt Cancer Center Clinical Trials website