Determinants of Multiple Health Risk Behaviors Among Latinos
| Tracking Information | |||||
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| First Received Date ICMJE | November 22, 2011 | ||||
| Last Updated Date | January 23, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | January 2022 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determinants of Cancer Risk Behaviors in Latinos [ Time Frame: 7 days ] [ Designated as safety issue: No ] Outcomes assessed through daily diary ecological momentary assessment (EMA) data and coded as yes (engaged in activity) or no (did not engage in activity). EMA assessments done over 7 contiguous days in a questionnaire computer-administered self-interview format. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01479257 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determinants of Multiple Health Risk Behaviors Among Latinos | ||||
| Official Title ICMJE | Determinants of Multiple Health Risk Behaviors Among Latinos | ||||
| Brief Summary | The goal of this research study is to learn how cultural, environmental, and interpersonal experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among Latino residents of Houston, Texas. |
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| Detailed Description | Study Participation: If you are eligible and choose to take part in this study, you will visit the clinic 2 times. At the first visit (this is the same visit where you complete the in-person screening test):
At the second visit, you will return the smart phone and the accelerometer. At both study visits, you will be asked to complete questionnaires that ask about your feelings, moods, and behaviors. You will complete 36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions). These questionnaires should take about 60 to 90 minutes to complete. Throughout the study, you will be contacted by mail, email, or telephone for reminders of clinic visits. You will be reminded before each clinic visit. You will be asked to provide the names and contact information for family and/or friends should the study staff have trouble reaching you. Length of Study: You will be considered off study when you complete the second visit. This is an investigational study. Up to 225 participants will take part in this study. All will be enrolled at MD Anderson. |
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| 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 | Bilingual Latinos in the Houston, Texas metropolitan area |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Bilingual Latinos
Bilingual Houston area Latinos surveyed for 7 continuous days with objective and subjective assessments using accelerometer and smart phone.
Interventions:
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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 | 225 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2022 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01479257 | ||||
| Other Study ID Numbers ICMJE | 2011-0696, 1K01CA157689, R25T CA57730 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | January 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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