Colorectal Cancer Screening Intervention Trial

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

Sponsors

Lead Sponsor: Morehouse School of Medicine

Collaborator: Centers for Disease Control and Prevention

Source Morehouse School of Medicine
Brief 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

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.

Overall Status Completed
Start Date March 2003
Completion Date July 2007
Primary Completion Date July 2007
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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
Measure 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:
Enrollment 360
Condition
Intervention

Intervention Type: Other

Intervention Name: Control

Description: Written materials only

Arm Group Label: Control

Intervention Type: Other

Intervention Name: Reduced out of pocket expense

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

Arm Group Label: Reduced out-of-pocket expense

Intervention Type: Behavioral

Intervention Name: one on one education

Description: one on one education with a health educator

Arm Group Label: One-on-one education

Intervention Type: Behavioral

Intervention Name: Group education

Description: Education in a small group

Arm Group Label: Group Education

Eligibility

Criteria:

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

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Daniel Blumenthal, M.D., M.P.H. Principal Investigator Morehouse School of Medicine
Location
Facility: Morehouse School of Medicine
Location Countries

United States

Verification Date

February 2009

Responsible Party

Name Title: Principal Investigator: D. Blumenthal

Organization: Morehouse School of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Control

Type: Placebo Comparator

Description: Written materials only

Label: Reduced out-of-pocket expense

Type: Experimental

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

Label: One-on-one education

Type: Experimental

Description: Individual education with a health educator on CRC screening

Label: Group Education

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov