Colorectal Cancer Screening Intervention Trial
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Purpose
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
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Colorectal Cancer Screening |
Other: Control Other: Reduced out of pocket expense Behavioral: one on one education Behavioral: Group education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Research on Community Cancer Control: Study of Colorectal Cancer Screening in the African American Population |
- 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.
- Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions:
| Enrollment: | 360 |
| Study Start Date: | March 2003 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Written materials only
|
Other: Control
Written materials only
|
|
Experimental: Reduced out-of-pocket expense
Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening
|
Other: Reduced out of pocket expense
Reimbursed up to $500 out of pocket expense for CRC screening
|
|
Experimental: One-on-one education
Individual education with a health educator on CRC screening
|
Behavioral: one on one education
one on one education with a health educator
|
|
Experimental: Group Education
Education on CRC screening in a small group with a health educator
|
Behavioral: Group education
Education in a small group
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Georgia | |
| Morehouse School of Medicine | |
| Atlanta, Georgia, United States, 30310-1495 | |
| Principal Investigator: | Daniel Blumenthal, M.D., M.P.H. | Morehouse School of Medicine |
More Information
No publications provided
| Responsible Party: | Principal Investigator: D. Blumenthal, Morehouse School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00265720 History of Changes |
| Other Study ID Numbers: | H57/CCH420680-05, H57/CCH420680-05 |
| Study First Received: | December 13, 2005 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Morehouse School of Medicine:
|
African Americans Colorectal Cancer Screening Colorectal Cancer Colorectal Cancer and African Americans Cancer Disparities |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 13, 2013