Colorectal Cancer Screening Intervention Trial

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Cancer Screening
• Intervention / Treatment: Other: Control; Other: Reduced out of pocket expense; Behavioral: one on one education; Behavioral: Group education

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30310-1495
      • Morehouse School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Daniel Blumenthal, M.D., M.P.H., Morehouse School of Medicine

Publications and helpful links

Helpful Links

• Morehouse School of Medicine - Prevention Research Center

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: December 13, 2005
• First Submitted That Met QC Criteria: December 13, 2005
• First Posted (Estimate): December 15, 2005

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Colorectal Cancer; African Americans; Colorectal Cancer Screening; Colorectal Cancer and African Americans; Cancer Disparities
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: H57/CCH420680-05