Increasing Colorectal Cancer Screening in African Americans



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 79
Updated:4/2/2016
Start Date:February 2008

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Increasing Colon Cancer Screening in Primary Care Among African Americans

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.

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.

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
We found this trial at
1
site
111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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mi
from
Philadelphia, PA
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