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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Targeted Psychoeducational Photo Novella; 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; Free FIT Kits distributed at study entry.; Behavioral: Culturally targeted Photo Novella Booklet; 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.
ACTIVE_COMPARATOR: Standard Brochure Intervention; 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; Free FIT Kits distributed at study entry.; Behavioral: Screen for Life Brochure; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: American Cancer Society, Inc.

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website
• A Community-Based Trial of Educational Interventions With Fecal Immunochemical Tests for Colorectal Cancer Screening Uptake Among Blacks in Community Settings

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2011
• Primary Completion (ACTUAL): October 23, 2015
• Study Completion (ACTUAL): May 3, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (ACTUAL): March 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MCC-16501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No