NCT03078348CompletedNot Applicable
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
H. Lee Moffitt Cancer Center and Research Institute2 sites in 1 country331 target enrollmentStarted: December 5, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 331
- Locations
- 2
- Primary Endpoint
- Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
Study Overview
Brief Summary
The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt.
- •Self identify as Black or African American
- •Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes
- •Have not had recent CRC screening per guidelines (never screened or overdue)
- •Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent).
- •Spouse or relatives of respondent are potentially eligible.
Exclusion Criteria
- •Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study.
- •Additional criteria may apply.
Outcomes
Primary Outcomes
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
Time Frame: 6 months post final enrollment
Fit screening uptake at 6 months. Number of participants who used and returned their FIT Kit, per study arm. A FIT Kit was provided to participants in both study arms for use and return.
Secondary Outcomes
- Rate of Diagnostic Colonoscopy(Post 6 month follow-up)
Investigators
Study Sites (2)
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