Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

Not Applicable

Completed

• Conditions: Colorectal Cancer; Colorectal Carcinoma
• Interventions: Other: Fecal Immunochemical Test (FIT) Kit; Behavioral: Screen for Life Brochure; Behavioral: Culturally targeted Photo Novella Booklet

• Registration Number: NCT03078348
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Primary Completion: 2015-10-23
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Completion: 2017-05-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Psychoeducational Photo Novella	Fecal Immunochemical Test (FIT) Kit	Fecal Immunochemical Test (FIT) Kit + Culturally targeted Photo Novella Booklet + culturally targeted reminders. This study involves participation at distinct time points: 1. Baseline 2. 6 month follow-up
Standard Brochure Intervention	Screen for Life Brochure	FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: 1. Baseline 2. Post 6 month follow-up
Targeted Psychoeducational Photo Novella	Culturally targeted Photo Novella Booklet	Fecal Immunochemical Test (FIT) Kit + Culturally targeted Photo Novella Booklet + culturally targeted reminders. This study involves participation at distinct time points: 1. Baseline 2. 6 month follow-up
Standard Brochure Intervention	Fecal Immunochemical Test (FIT) Kit	FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: 1. Baseline 2. Post 6 month follow-up

Primary Outcome Measures

Name	Time	Method
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm	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 Outcome Measures

Name	Time	Method
Rate of Diagnostic Colonoscopy	Post 6 month follow-up	Number of participants who participated in a diagnostic colonoscopy, post test kit return.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States