Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients
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ClinicalTrials.gov Identifier: NCT00838318 |
Recruitment Status
:
Completed
First Posted
: February 6, 2009
Last Update Posted
: July 30, 2012
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Tracking Information | ||||
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First Submitted Date | February 5, 2009 | |||
First Posted Date | February 6, 2009 | |||
Last Update Posted Date | July 30, 2012 | |||
Study Start Date | February 2004 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives. [ Time Frame: 5 Years ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00838318 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
To study how these families communicate with each other and health care providers about colorectal cancer risk and screening. [ Time Frame: 5 Years ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients | |||
Official Title | Colorectal Cancer (CRC) Screening in First-Degree Relatives (FDRs) of Hispanic CRC Patients | |||
Brief Summary | Primary Objectives:
Secondary Objective: 1) To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the institutional patient database and/or MDACC clinics. |
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Detailed Description | CRC PATIENTS AND THEIR FDRS: You will be asked to complete a questionnaire by telephone interview. The study researcher who calls you will ask for your permission to audiotape the interview. The questionnaire asks about your awareness of screening tests for colorectal cancer, your family's past use of these screening tests, your attitudes toward colorectal cancer screening, and how you discuss colorectal cancer risk and screening with your family and health care providers. Some demographic information also will be collected (such as your age or marital status). The questionnaire will take between 30 and 45 minutes to complete. Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years). This is an investigational study. Up to 60 colorectal cancer patients and their close relatives may be enrolled in the study. All will be enrolled at M. D. Anderson. KEY INFORMANT: You will be asked to complete a psychosocial interview either in person or by telephone. The study staff member interviewing you will ask you for permission to audiotape the interview. You will be asked to review the interview guides for colorectal cancer patients and their first degree relatives (FDRs), and provide feedback about them. The interviewer will ask for your opinions about Hispanics' awareness and understanding of colorectal cancer screening. You will also be asked for your opinion about cultural beliefs and practices that may influence participation in colorectal cancer screening. The interview will take between 30 and 45 minutes to complete. Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years). This is an investigational study. Up to 15 key informants may be enrolled in this study. All will be enrolled at M. D. Anderson. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Key Informants from Houston Hispanic Health Coaltion having professional expertise relevant to this study; MDACC Hispanic/Latino CRC Patients, age 18 - 60 years with first degree relatives between age 40 - 70; First-degree relatives (siblings and children) of the MDACC CRC cancer patients recruited to this study, who are aged 40 - 70 years. | |||
Condition | Colorectal Cancer | |||
Intervention | Behavioral: Interview
Audiotaped Phone Interview/Survey, 30 - 45 minutes. |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
26 | |||
Original Estimated Enrollment |
75 | |||
Actual Study Completion Date | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00838318 | |||
Other Study ID Numbers | 2004-0039 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor | M.D. Anderson Cancer Center | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | July 2012 |