Colorectal Cancer Screening Intervention Trial

Study Overview
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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.

Official Title
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Research on Community Cancer Control: Study of Colorectal Cancer Screening in the African American Population

Conditions
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Colorectal Cancer, Colorectal Cancer Screening

Intervention / Treatment
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* Other: Control
* Other: Reduced out of pocket expense
* Behavioral: one on one education
* Behavioral: Group education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Written materials only | Other: Control<br>* Written materials only<br>|
| Experimental: Reduced out-of-pocket expense<br>Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening | Other: Reduced out of pocket expense<br>* Reimbursed up to $500 out of pocket expense for CRC screening<br>|
| Experimental: One-on-one education<br>Individual education with a health educator on CRC screening | Behavioral: one on one education<br>* one on one education with a health educator<br>|
| Experimental: Group Education<br>Education on CRC screening in a small group with a health educator | Behavioral: Group education<br>* Education in a small group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions: |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Disparities, African Americans, Colorectal Cancer Screening, Colorectal Cancer, Colorectal Cancer and African Americans