NCT03078361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

January 11, 2023

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

March 3, 2017

Last Update Submit

January 10, 2023

Conditions

Keywords

cancer screeningcolon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rate of Receipt of I-FOBT from Participants

    Up to 4 months

  • Rate of Receipt of Assessments from Participants

    Up to 4 months

Study Arms (2)

LATINOS CARES Toolkit

ACTIVE COMPARATOR

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) KitBehavioral: LATINOS CARES Toolkit

Standard Intervention (SI)

ACTIVE COMPARATOR

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) KitBehavioral: Standard Intervention

Interventions

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 ToolkitStandard Intervention (SI)

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

LATINOS CARES Toolkit

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

Standard Intervention (SI)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Clement Gwede, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 13, 2017

Study Start

April 28, 2014

Primary Completion

July 14, 2016

Study Completion

October 26, 2022

Last Updated

January 11, 2023

Record last verified: 2022-08

Locations