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Use of Screening Colonoscopy Among Minority Women and Men

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ClinicalTrials.gov Identifier: NCT00613873
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : January 15, 2009
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Colorectal Screening Procedure: Colonoscopy and Questionnaire

Study Design

Study Type : Observational
Actual Enrollment : 611 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men
Study Start Date : July 2003
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Women participating in a community based mammography or cervical screening program will also participate in colonoscopy screening. Participation will be measured by stating an interest in colorectal cancer screening and then following through with colonoscopy screening. Furthermore we will assess whether those complying with colonoscopy will also recommend colonoscopy screening for their spouses or household members.
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.

Outcome Measures

Primary Outcome Measures :
  1. 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). [ Time Frame: conclusion of the study ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: conclusion of the study ]
  2. Determine the feasibility of promoting CRCS among spouses (and other members of the household) of minority women who have undergone screening colonoscopy. [ Time Frame: conclusion of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigators or research team at Memorial Sloan-Kettering Cancer Center(MSKCC). The study will be offered to all eligible women who come for breast or cervical cancer screening at The Breast Examination Center of Harlem during the study period

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613873

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Breast Examination Center of Harlem
New York, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
North General Hospital, New York
Ralph Lauren Center for Cancer Care and Prevention
Principal Investigator: Moshe Shike, MD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moshe Shike, M.D., Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00613873     History of Changes
Other Study ID Numbers: 03-066
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009

Keywords provided by Memorial Sloan Kettering Cancer Center: