Colorectal Cancer Screening Intervention Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Morehouse School of Medicine
ClinicalTrials.gov Identifier:
NCT00265720
First received: December 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
  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

Resource links provided by NLM:


Further study details as provided by Morehouse School of Medicine:

Primary Outcome Measures:
  • 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:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265720

Locations
United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310-1495
Sponsors and Collaborators
Morehouse School of Medicine
Investigators
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 July 26, 2014