Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

NCT ID: NCT03078348

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-05

Study Completion Date

2017-05-03

Brief Summary

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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

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Conditions

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Colorectal Cancer Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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:

1. Baseline
2. 6 month follow-up

Group Type ACTIVE_COMPARATOR

Fecal Immunochemical Test (FIT) Kit

Intervention Type OTHER

Free FIT Kits distributed at study entry.

Culturally targeted Photo Novella Booklet

Intervention Type 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.

Standard Brochure Intervention

FIT Kit + Screen for Life Brochure + standard reminders. This study involves participation at distinct time points:

1. Baseline
2. Post 6 month follow-up

Group Type ACTIVE_COMPARATOR

Fecal Immunochemical Test (FIT) Kit

Intervention Type OTHER

Free FIT Kits distributed at study entry.

Screen for Life Brochure

Intervention Type 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.

Interventions

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Fecal Immunochemical Test (FIT) Kit

Free FIT Kits distributed at study entry.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement Gwede, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Related Links

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http://onlinelibrary.wiley.com/doi/10.1002/cncr.30207/full

A Community-Based Trial of Educational Interventions With Fecal Immunochemical Tests for Colorectal Cancer Screening Uptake Among Blacks in Community Settings

Other Identifiers

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MCC-16501

Identifier Type: -

Identifier Source: org_study_id

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