Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

NCT03078348 | Completed

• 1 other identifier: MCC-16501
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Carcinoma

Keywords

cancer screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Diagnostic Colonoscopy

  Post 6 month follow-up

Study Arms (2)

Targeted Psychoeducational Photo Novella

ACTIVE COMPARATOR

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

Other: Fecal Immunochemical Test (FIT) Kit; Behavioral: Culturally targeted Photo Novella Booklet

Standard Brochure Intervention

ACTIVE COMPARATOR

FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points: 1. Baseline 2. Post 6 month follow-up

Other: Fecal Immunochemical Test (FIT) Kit; Behavioral: Screen for Life Brochure

Interventions

Fecal Immunochemical Test (FIT) Kit OTHER

Free FIT Kits distributed at study entry.

Standard Brochure Intervention; Targeted Psychoeducational Photo Novella

Culturally targeted Photo Novella Booklet BEHAVIORAL

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.

Targeted Psychoeducational Photo Novella

Screen for Life Brochure BEHAVIORAL

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.

Standard Brochure Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Receptor Protein-Tyrosine Kinases; Mass Screening

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Clement Gwede, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 13, 2017
• Study Start: December 5, 2011
• Primary Completion: October 23, 2015
• Study Completion: May 3, 2017
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)