Use of Screening Colonoscopy Among Minority Women and Men
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2008 | ||||
| Last Updated Date | January 14, 2009 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00613873 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Screening Colonoscopy Among Minority Women and Men | ||||
| Official Title ICMJE | A Model Program for Increasing Use of Screening Colonoscopy Among Minority Women and Men | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Colorectal Screening | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | 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.
Intervention: Procedure: Colonoscopy and Questionnaire |
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| Publications * | Shike M, Schattner M, Genao A, Grant W, Burke M, Zauber A, Russo L, Cuyjet V. Expanding colorectal cancer screening among minority women. Cancer. 2011 Jan 1;117(1):70-6. Epub 2010 Oct 25. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 611 | ||||
| Completion Date | January 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00613873 | ||||
| Other Study ID Numbers ICMJE | 03-066 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Moshe Shike, M.D., Memorial Sloan Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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