Increasing Colorectal Cancer Screening in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00893295
First received: May 2, 2009
Last updated: December 17, 2013
Last verified: July 2009
  Purpose

RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Finding out what affects a patient's decision to undergo screening tests may help increase the number of patients who undergo regular screening for cancer. It is not yet known whether personalized invitations to undergo colorectal cancer screening are more effective than standard screening reminders.

PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer screening in African Americans.


Condition Intervention Phase
Colorectal Cancer
Other: informational intervention
Other: medical chart review
Other: screening questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: barium enema injection
Procedure: colon imaging study
Procedure: screening colonoscopy
Procedure: sigmoidoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Screening
Official Title: Increasing Colon Cancer Screening in Primary Care Among African Americans

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey [ Designated as safety issue: No ]
  • Intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy-related CRC screening measured with 6 to 10 Likert-type items on both the baseline and end ... [ Designated as safety issue: No ]

Estimated Enrollment: 896
Study Start Date: February 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To assess the intervention impact on colorectal cancer (CRC) screening utilization over a 6-month observation period in African-American participants.
  • To assess the intervention impact on CRC screening preference, classified into three levels (i.e., "decided not to screen or never heard of," "undecided," or "decided to screen"), based on data obtained from both the endpoint chart audit and the endpoint survey.
  • To assess intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy related to CRC screening measured with 6 to 10 Likert-type items on both the baseline and endpoint surveys.
  • To analyze intervention cost-effectiveness, from the societal perspective and from the more limited perspective of the provider and payer, focusing on the average and incremental cost per additional person who is compliant (i.e., has a CRC screening test during the observation period) for each alternative intervention and estimate the cost per life-year saved.

OUTLINE: This is a multicenter study. Participants are stratified according to practice. Participants are randomized to 1 of 2 intervention arms.

  • Arm I (standard-intervention group): Participants receive a personalized screening invitation letter encouraging selection and performance of one of the screening tests, a generic colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment. After 45 days, participants who have not been screened receive a reminder letter.
  • Arm II (tailored-navigation intervention group): Participants receive a CRC screening invitation letter and materials that are tailored to the individual's preferred screening test strategy (i.e., SBT; SBT and instructions for arranging flexible sigmoidoscopy, instructions for arranging flexible sigmoidoscopy; or instructions for arranging colonoscopy). After 30 days, participants who have not been screened will receive a reminder by telephone. Those participants who have undergone screening will be congratulated for taking the time and preventative action, and be encouraged to continue future screenings. After 45 days, participants who have not been screened receive a reminder letter.

Participants are assessed by a baseline survey consisting of personal background, cognitive and psychological representations, social support and influence, intention, and decision stage related to screening SBT and colonoscopy preference. Data obtained from the endpoint survey assessing whether participants and their providers discussed CRC screening before the study and opinions about the intervention, and an endpoint chart audit to gather data on participant CRC screening exam dates and exam results (i.e., screening SBT, flexible sigmoidoscopy, colonoscopy, double-contrast barium enema [DCBE] x-ray) are assessed for group differences.

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • African-American participants who receive medical care in a large, urban primary care practice setting and are eligible for colorectal cancer (CRC) screening
  • Noncompliant with CRC screening in terms of American Cancer Society guidelines
  • Attended an office visit within the past 2 years

PATIENT CHARACTERISTICS:

  • No family history of colorectal cancer diagnosed before the age of 60 years
  • No prior diagnosis of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00893295

Locations
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
Sponsors and Collaborators
Kimmel Cancer Center (KCC)
Investigators
Principal Investigator: Ronald Myers, PhD Jefferson Medical College of Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald Myers, Jefferson Medical College of Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00893295     History of Changes
Other Study ID Numbers: CDR0000635953, TJUH-RSGT-08-017-01-CPPB, 08G.89
Study First Received: May 2, 2009
Last Updated: December 17, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
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 29, 2014