Clinical trial NCT03078348: Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
Official title: Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Carcinoma
Keywords: cancer screening
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-03-13
Enrollment: 331
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this modified "block" random assignment, all individuals recruited from the same geographic unit will receive the intervention assigned to that area in order to reduce intervention contamination. Individuals will not be made aware of their randomization (intervention) condition until after baseline assessment. The research assistants will also be assigned at random to work with one geographic area (i.e., one intervention condition) in order to reduce risk of intervention contamination by study staff.
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
timeFrame: 6 months post final enrollment
Secondary outcomes:
measure: Rate of Diagnostic Colonoscopy
timeFrame: Post 6 month follow-up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Clement Gwede, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: