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Increasing Colon Cancer Screening in Primary Care Among African Americans


Phase 3
50 Years
79 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Increasing Colon Cancer Screening in Primary Care Among 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period

Safety Issue:

No

Principal Investigator

Ronald Myers, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jefferson Medical College of Thomas Jefferson University

Authority:

Unspecified

Study ID:

CDR0000635953

NCT ID:

NCT00893295

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107