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Increasing Colorectal Cancer Screening in African Americans

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
informational intervention
medical chart review
screening questionnaire administration
study of socioeconomic and demographic variables
barium enema injection
colon imaging study
screening colonoscopy
sigmoidoscopy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey
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 ...

Full Information

First Posted
May 2, 2009
Last Updated
December 17, 2013
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00893295
Brief Title
Increasing Colorectal Cancer Screening in African Americans
Official Title
Increasing Colon Cancer Screening in Primary Care Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
896 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
screening questionnaire administration
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
barium enema injection
Intervention Type
Procedure
Intervention Name(s)
colon imaging study
Intervention Type
Procedure
Intervention Name(s)
screening colonoscopy
Intervention Type
Procedure
Intervention Name(s)
sigmoidoscopy
Primary Outcome Measure Information:
Title
Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period
Secondary Outcome Measure Information:
Title
Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey
Title
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 ...

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Myers, PhD
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Phone
215-955-6084

12. IPD Sharing Statement

Learn more about this trial

Increasing Colorectal Cancer Screening in African Americans

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