Back to resultsLatinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
Primary Purpose
Colorectal Cancer, Colorectal Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
LATINOS CARES Toolkit
Standard Intervention
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring cancer screening, colon
Eligibility Criteria
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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LATINOS CARES Toolkit
Standard Intervention (SI)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of Receipt of I-FOBT from Participants
BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).
Rate of Receipt of Assessments from Participants
BENCHMARK: Receipt of Assessments.
Full Information
NCT ID
NCT03078361
First Posted
March 3, 2017
Last Updated
January 10, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health, Bankhead-Coley Cancer Research Program
1. Study Identification
Unique Protocol Identification Number
NCT03078361
Brief Title
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
Official Title
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2014 (Actual)
Primary Completion Date
July 14, 2016 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health, Bankhead-Coley Cancer Research Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Carcinoma
Keywords
cancer screening, colon
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LATINOS CARES Toolkit
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Intervention (SI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LATINOS CARES Toolkit
Intervention Description
DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.
Intervention Type
Behavioral
Intervention Name(s)
Standard Intervention
Intervention Description
Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.
Primary Outcome Measure Information:
Title
Rate of Feedback from Community Advisory Board
Description
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.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Rate of Receipt of I-FOBT from Participants
Description
BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).
Time Frame
Up to 4 months
Title
Rate of Receipt of Assessments from Participants
Description
BENCHMARK: Receipt of Assessments.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clement Gwede, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35238785
Citation
Chavarria EA, Christy SM, Feng H, Miao H, Abdulla R, Gutierrez L, Lopez D, Sanchez J, Gwede CK, Meade CD. Online Health Information Seeking and eHealth Literacy Among Spanish Language-Dominant Latino Adults Receiving Care in a Community Clinic: Secondary Analysis of Pilot Randomized Controlled Trial Data. JMIR Form Res. 2022 Oct 13;6(10):e37687. doi: 10.2196/37687.
Results Reference
derived
PubMed Identifier
33990120
Citation
Christy SM, Cousin LA, Sutton SK, Chavarria EA, Abdulla R, Gutierrez L, Sanchez J, Lopez D, Gwede CK, Meade CD. Characterizing Health Literacy Among Spanish Language-Preferring Latinos Ages 50-75. Nurs Res. 2021 Set/Oct 01;70(5):344-353. doi: 10.1097/NNR.0000000000000519.
Results Reference
derived
Links:
URL
https://moffitt.org/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
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