Questionnaire and Fall Risk Assessment
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2009 | ||||
| Last Updated Date | July 31, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number Patient Falls + Activity Limitations Using Functional Tests [ Time Frame: 45 minutes total to complete during already-scheduled clinic visit ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To learn if answers to questions during an interview can help researchers predict how well individuals function physically and if they are at a high risk for falls. [ Time Frame: 6 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00836238 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 | Questionnaire and Fall Risk Assessment | ||||
| Official Title ICMJE | A Cross-Sectional Study of the Predictability of a Questionnaire About Difficulty in Climbing Up or Down Stairs in Objective Measures of Functional Status in Elderly Patients With Prostate Cancer | ||||
| Brief Summary | The goal of this research study is to learn if your answers to questions during an interview can help researchers predict how well you function physically and if you are at a high risk for falls. Primary Objectives: -To determine how accurately a simple questionnaire can predict three objective measures of function in elderly patients with prostate cancer. Secondary Objectives:
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| Detailed Description | Physical Function Interview: If you agree to take part in this study, you will be asked 6 questions. The first 2 questions ask about your physical ability to walk up and down stairs. The next 4 questions ask about your history of falling down in the last year, symptoms of depression, loss of urinary control, vision problems, and your ability to function physically. If you report that you have fallen down more than 3 times in the last year, you will automatically be referred for a physical therapy evaluation at M. D. Anderson. Physical Function Tests: After you have completed the questionnaires, you will perform 3 physical function tests:
Symptom Assessment Interview: After you complete the physical function tests, you will be asked to rate any symptoms you experience on a scale from 0-10 (with 0 being the best and 10 being worst). You will be asked to rate symptoms of things such as pain, fatigue, nausea, depression, anxiety, drowsiness, and shortness of breath. Medical Record Information: Information will be collected from your medical record. This information will include your age, race, gender, weight, height, body mass index, disease diagnosis, history of chemotherapy and medications, and medical history. Additional Information: The physical function interview, tests of physical function, and symptom assessment interview will take about 45 minutes total to complete during an already-scheduled visit to the clinic. Length of Study: Your participation on this study will be over after you have completed the questionnaires, physical function tests, and the symptom assessment. This is an investigational study. Up to 60 people will take part in this study. All will be enrolled at M. D. 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 | Males with prostate cancer, 65 years of age or older, who able to ambulate with or without an assistive device, without assistance from a person. |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Questionnaire + Fall Risk Assessment
Physical Function Interview + Physical Function Tests + Symptom Assessment Interview
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 | Completed | ||||
| Enrollment ICMJE | 34 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 65 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 | NCT00836238 | ||||
| Other Study ID Numbers ICMJE | 2008-0779 | ||||
| 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 | July 2012 | ||||
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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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