Back to resultsIncreasing Access to Colorectal Cancer Testing (IACCT) for Blacks (IACCT)
Primary Purpose
Colorectal Cancer, Colorectal Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Immunochemical Test (FIT) Kit
Culturally targeted Photo Novella Booklet
Screen for Life Brochure
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring cancer 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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Targeted Psychoeducational Photo Novella
Standard Brochure Intervention
Arm Description
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
FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: Baseline Post 6 month follow-up
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of Diagnostic Colonoscopy
Number of participants who participated in a diagnostic colonoscopy, post test kit return.
Full Information
NCT ID
NCT03078348
First Posted
March 3, 2017
Last Updated
November 8, 2022
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03078348
Brief Title
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
Acronym
IACCT
Official Title
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2011 (Actual)
Primary Completion Date
October 23, 2015 (Actual)
Study Completion Date
May 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Carcinoma
Keywords
cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
331 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Psychoeducational Photo Novella
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard Brochure Intervention
Arm Type
Active Comparator
Arm Description
FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points:
Baseline
Post 6 month follow-up
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test (FIT) Kit
Intervention Description
Free FIT Kits distributed at study entry.
Intervention Type
Behavioral
Intervention Name(s)
Culturally targeted Photo Novella Booklet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Screen for Life Brochure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Fecal Immunochemical Test (FIT) Kit Return Per Study Arm
Description
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.
Time Frame
6 months post final enrollment
Secondary Outcome Measure Information:
Title
Rate of Diagnostic Colonoscopy
Description
Number of participants who participated in a diagnostic colonoscopy, post test kit return.
Time Frame
Post 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clement Gwede, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
We'll reach out to this number within 24 hrs