Colorectal Cancer Screening Intervention Trial

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265720
• Other study ID #: H57/CCH420680-05
• Secondary ID: H57/CCH420680-05
• Status: Completed
• Phase: N/A
• First received: December 13, 2005
• Last updated: February 3, 2009
• Start date: March 2003
• Est. completion date: July 2007

Study information

• Verified date: February 2009
• Source: Morehouse School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Other:
• Control
Written materials only
• Reduced out of pocket expense
Reimbursed up to $500 out of pocket expense for CRC screening

Behavioral:
• one on one education
one on one education with a health educator
• Group education
Education in a small group

Locations

Country	Name	City	State
United States	Morehouse School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Morehouse School of Medicine	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions: