Use of Screening Colonoscopy Among Minority Women and Men

Colorectal Screening Clinical Trial

Official title:

A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613873
• Other study ID #: 03-066
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: January 14, 2009
• Start date: July 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an early stage, when it has a much higher chance of cure. Screening can also help to find polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed before it turns into cancer. Even though screening can save lives, not enough people in the country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths from this cancer than other places in the U.S. because too many people do not get screened. By the time a person has symptoms, the cancer may be at a late stage, when it is much harder to cure.

We are doing this study to see if we can increase the number of people in Harlem who get screened. We plan to tell women about the screening when they have a mammogram or pap test. We will also ask them what they know and think about colorectal cancer. And, we will see if they get other members of their household to be screened.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age > or equal to 50

• Availability by telephone

Exclusion Criteria:

• History of colorectal cancer screening (fecal occult blood testing annually for last 3 years; colonoscopy within the last 10 years)

• History of colorectal cancer

• Serious illness which precludes colonoscopy (severe heart disease; severe pulmonary disease; uncontrolled diabetes; uncontrolled hypertension; other medical contraindication)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Screening

Intervention

Procedure:
• Colonoscopy and Questionnaire
Pt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview.

Locations

Country	Name	City	State
United States	Breast Examination Center of Harlem	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	North General Hospital, New York, Ralph Lauren Center for Cancer Care and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of using a community screening mammography center to recruit minority women form a low income community to undergo colorectal cancer screening (CRCS).		conclusion of the study	No
Secondary	Identify individual level barriers (demographic, financial, and psychological) to CRCS among minority women who are already participating in screening for another cancer (breast or cervical)		conclusion of the study	No
Secondary	Determine the feasibility of promoting CRCS among spouses (and other members of the household) of minority women who have undergone screening colonoscopy.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center