Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

Study Overview
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Brief Summary
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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.

Official Title
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Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

Conditions
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Colorectal Cancer, Colorectal Carcinoma

Intervention / Treatment
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* Other: Fecal Immunochemical Test (FIT) Kit
* Behavioral: Culturally targeted Photo Novella Booklet
* Behavioral: Screen for Life Brochure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Targeted Psychoeducational Photo Novella<br>Fecal Immunochemical Test (FIT) Kit + Culturally targeted Photo Novella Booklet + culturally targeted reminders. This study involves participation at distinct time points: Baseline 6 month follow-up | Other: Fecal Immunochemical Test (FIT) Kit<br>* Free FIT Kits distributed at study entry.<br>Behavioral: Culturally targeted Photo Novella Booklet<br>* Culturally targeted Photo Novella Booklet + culturally targeted reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.<br>|
| Active Comparator: Standard Brochure Intervention<br>FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: Baseline Post 6 month follow-up | Other: Fecal Immunochemical Test (FIT) Kit<br>* Free FIT Kits distributed at study entry.<br>Behavioral: Screen for Life Brochure<br>* Screen for Life Brochure + standard reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm | 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. | 6 months post final enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Diagnostic Colonoscopy | Number of participants who participated in a diagnostic colonoscopy, post test kit return. | Post 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer screening