Colorectal Cancer Screening Intervention Trial

NCT ID: NCT00265720

Last Updated: 2009-02-04

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

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-07-31

Brief Summary

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Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening

Detailed Description

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Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.

The purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.

Participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.

Conditions

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Colorectal Cancer Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Control

Written materials only

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Written materials only

Reduced out-of-pocket expense

Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening

Group Type EXPERIMENTAL

Reduced out of pocket expense

Intervention Type OTHER

Reimbursed up to $500 out of pocket expense for CRC screening

One-on-one education

Individual education with a health educator on CRC screening

Group Type EXPERIMENTAL

one on one education

Intervention Type BEHAVIORAL

one on one education with a health educator

Group Education

Education on CRC screening in a small group with a health educator

Group Type EXPERIMENTAL

Group education

Intervention Type BEHAVIORAL

Education in a small group

Interventions

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Control

Written materials only

Intervention Type OTHER

Reduced out of pocket expense

Reimbursed up to $500 out of pocket expense for CRC screening

Intervention Type OTHER

one on one education

one on one education with a health educator

Intervention Type BEHAVIORAL

Group education

Education in a small group

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* African American
* Previously not screened for colorectal cancer according to ACS guidelines
* Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
* 50 years of age or older

Exclusion Criteria

* Non-African American
* Less than 50 years of age
* Previously screened consistent with ACS guideline
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Morehouse School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Morehouse School of Medicine

Principal Investigators

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Daniel Blumenthal, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Morehouse School of Medicine

Locations

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Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status

Countries

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United States

Related Links

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http://www.msm.edu/prc/

Morehouse School of Medicine - Prevention Research Center

Other Identifiers

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H57/CCH420680-05

Identifier Type: -

Identifier Source: secondary_id

H57/CCH420680-05

Identifier Type: -

Identifier Source: org_study_id

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