Increasing Colorectal Cancer Screening in African Americans
NCT ID: NCT00893295
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
896 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer screening in African Americans.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SCREENING
NONE
Interventions
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informational intervention
medical chart review
screening questionnaire administration
study of socioeconomic and demographic variables
barium enema injection
colon imaging study
screening colonoscopy
sigmoidoscopy
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
79 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Jefferson Medical College of Thomas Jefferson University
Principal Investigators
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Ronald Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Jefferson Medical College of Thomas Jefferson University
Locations
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Role: primary
Other Identifiers
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TJUH-RSGT-08-017-01-CPPB
Identifier Type: -
Identifier Source: secondary_id
08G.89
Identifier Type: -
Identifier Source: secondary_id
CDR0000635953
Identifier Type: -
Identifier Source: org_study_id