Increasing Colorectal Cancer Screening in African Americans

Colorectal Cancer Clinical Trial

Official title:

Increasing Colon Cancer Screening in Primary Care Among African Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00893295
• Other study ID #: CDR0000635953
• Secondary ID: TJUH-RSGT-08-017
• Status: Recruiting
• Phase: Phase 3
• First received: May 2, 2009
• Last updated: December 17, 2013
• Start date: February 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 896
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• informational intervention

• medical chart review

• screening questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• barium enema injection

• colon imaging study

• screening colonoscopy

• sigmoidoscopy

Locations

Country	Name	City	State
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kimmel Cancer Center (KCC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period			No
Secondary	Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey			No
Secondary	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 ...			No