Clinical trial NCT00893295: Increasing Colorectal Cancer Screening in African Americans
Official title: Increasing Colon Cancer Screening in Primary Care Among African Americans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-05
Enrollment: 896
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: SCREENING

Brief summary: 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.

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 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

Primary outcomes:
measure: Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period
Secondary outcomes:
measure: Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey
measure: 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 ...
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Ronald Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: