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

NCT ID: NCT03078361

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-28

Study Completion Date

2022-10-26

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.

Detailed Description

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Conditions

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Colorectal Cancer Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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LATINOS CARES Toolkit

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.

Group Type ACTIVE_COMPARATOR

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Intervention Type OTHER

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.

LATINOS CARES Toolkit

Intervention Type BEHAVIORAL

DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.

Standard Intervention (SI)

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.

Group Type ACTIVE_COMPARATOR

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Intervention Type OTHER

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.

Standard Intervention

Intervention Type BEHAVIORAL

Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.

Interventions

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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.

Intervention Type OTHER

LATINOS CARES Toolkit

DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.

Intervention Type BEHAVIORAL

Standard Intervention

Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida Department of Health

OTHER_GOV

Sponsor Role collaborator

Bankhead-Coley Cancer Research Program

UNKNOWN

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement Gwede, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35238785 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33990120 (View on PubMed)

Related Links

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https://moffitt.org/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

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MCC-17665

Identifier Type: -

Identifier Source: org_study_id

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