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A Community-Based Educational Intervention to Improve Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392050
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date May 13, 2020
First Posted Date May 18, 2020
Last Update Posted Date August 16, 2022
Actual Study Start Date January 31, 2020
Estimated Primary Completion Date September 5, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2020)		 Successful completion of the key contact interviews and focus groups leading to the development of the culturally tailored educational intervention [ Time Frame: Up to 4 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Community-Based Educational Intervention to Improve Colorectal Cancer Screening
Official Title A Community-Based Educational Intervention to Improve Colorectal Cancer Screening
Brief Summary This study investigates the facilitators and barriers to colorectal cancer screening in underserved populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area. Learning what encourages people and what keeps people from getting colorectal cancer screening may help researchers develop an educational tool for colorectal cancer screening that addresses colorectal cancer knowledge, beliefs, and cultural factors in underserved populations.
Detailed Description

PRIMARY OBJECTIVE:

I. Develop a culturally tailored colorectal cancer education intervention for underserved and under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area.

OUTLINE:

KEY CONTACT INTERVIEWS: Participants participate an interviews over 60 minutes focusing on identifying facilitators and barriers to colorectal cancer screening, essential cultural factors to include in the educational intervention, and insights into the best use of the National Cancer Institute (NCI)'s Screen to Save materials.

FOCUS GROUPS: Participants attend focus groups over 60-90 minutes to examine and define further facilitators and barriers to colorectal cancer, cancer knowledge and beliefs, essential cultural factors to include in the educational intervention, insights into the best use of the NCI's Screen to Save materials, and identification of factors to consider for dissemination and sustainability.

After completion of study, participants are followed up for up to 12 weeks.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area
Condition Colorectal Carcinoma
Intervention
  • Other: Interview
    Complete interview
  • Other: Focus Group
    Attend focus groups
  • Other: Questionnaire Administration
    Ancillary studies
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 13, 2020)		 90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 5, 2025
Estimated Primary Completion Date September 5, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • • Focus Groups may be facilitated in Chinese (Mandarin), English, or Spanish depending on participant preference

Exclusion Criteria:

  • • Individuals who do not meet the inclusion criteria

    • Individuals who have been diagnosed with colorectal cancer
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ana Maria Lopez 215-503-6413 AnaMaria.Lopez@jefferson.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04392050
Other Study ID Numbers 20F.051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Thomas Jefferson University
Original Responsible Party Same as current
Current Study Sponsor Thomas Jefferson University
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Ana Marie Lopez Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date August 2022