Screening for Familial Colorectal Cancer (CRC) Patients
| Tracking Information | |||||
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| First Received Date ICMJE | March 3, 2008 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Psychosocial + External factors influencing CRC patients' communication with FDRs about CRC risk & screening information [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00632515 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers. [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening for Familial Colorectal Cancer (CRC) Patients | ||||
| Official Title ICMJE | Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients | ||||
| Brief Summary | The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers. Objectives:
Using measures of knowledge, health beliefs and behavior, family closeness and subjective norms, distress, provider interactions, benefits/barriers, and background variables (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors associated with CRC screening behavior (specifically, colonoscopy adherence). |
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| Detailed Description | You will be interviewed by a member of the study staff over the telephone. You will be asked about your awareness of screening tests for colorectal cancer, and your attitudes toward colorectal cancer screening. You also will also be asked about your family's past use of these screening tests, 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. This is an investigational study. Up to 325 colorectal cancer patients and their close relatives may take part in the study. All will be enrolled MD Anderson. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with diagnosis of Colorectal Cancer at or before age 60 years, and their First Degree Relatives (FDRs) who are age 40 years or older. |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Behavioral: Questionnaire
Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.
Other Name: Survey |
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| Study Group/Cohort (s) | Questionnaire
Patients with Colorectal Cancer and their First Degree Relatives (FDRs).
Intervention: Behavioral: Questionnaire |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 325 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00632515 | ||||
| Other Study ID Numbers ICMJE | 2004-0316 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | May 2013 | ||||
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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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