Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

Colorectal Cancer Clinical Trial

— IACCT  

Official title:

Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078348
• Other study ID #: MCC-16501
• Status: Completed
• Phase: N/A
• Start date: December 5, 2011
• Est. completion date: May 3, 2017

Study information

• Verified date: November 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: May 3, 2017
• Est. primary completion date: October 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Diagnostic Colonoscopy	Number of participants who participated in a diagnostic colonoscopy, post test kit return.	Post 6 month follow-up

External Links

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