Questionnaire and Fall Risk Assessment
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
1 other identifier
observational
34
1 country
1
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:
- To assess the correlations between three functional tests and the number of self-reported falls in elderly patients with prostate cancer.
- To determine risk factors related to number of falls in elderly prostate cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 1, 2012
July 1, 2012
4 months
January 26, 2009
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number Patient Falls + Activity Limitations Using Functional Tests
45 minutes total to complete during already-scheduled clinic visit
Study Arms (1)
Questionnaire + Fall Risk Assessment
Physical Function Interview + Physical Function Tests + Symptom Assessment Interview
Interventions
Physical Function and Symptom Assessment Interviews
Eligibility Criteria
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.
You may qualify if:
- Patients must have the ability to understand and willingness to sign a written informed consent document.
- Patients must be able to ambulate with or without an assistive device, without assistance from a person.
- Patients must be 65 years old or older.
- Patients must have a diagnosis of prostate cancer
- Patients must have received androgen deprivation therapy (ADT) for their prostate cancer for at least 3 months and were responding to treatment as determined by prostate-specific antigen criteria.
- Patients have received chemotherapy within last month.
- Patients must speak English.
You may not qualify if:
- Patients who decline to participate or who are determined incapable of completing the study.
- Active Central Nervous System (CNS) disease such as clinically-evident CNS metastases or leptomeningeal disease, dementia, or encephalopathy (per treating physician's assessment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Guo, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
February 4, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 1, 2012
Record last verified: 2012-07