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Use of Screening Colonoscopy Among Minority Women and Men

This study has been completed.
Sponsor:
Collaborators:
North General Hospital, New York
Ralph Lauren Center for Cancer Care and Prevention
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00613873
First received: January 31, 2008
Last updated: January 14, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Colorectal Screening
 Procedure: Colonoscopy and Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 611
Study Start Date: July 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613873

Locations
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
Investigators
Principal Investigator: Moshe Shike, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided by Memorial Sloan-Kettering Cancer Center

Additional 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
Study First Received: January 31, 2008
Last Updated: January 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
colonoscopy

ClinicalTrials.gov processed this record on May 23, 2013