Questionnaire and Fall Risk Assessment

July 31, 2012 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  • For the first test, you will sit in a chair, stand up, walk 10 feet as quickly and safely as possible, turn around, return to the chair and sit again. This test will be timed. You will perform this test 3 times, the average of the times will be recorded. There will be no rest break between each test.
  • For the next test, you will stand only on 1 leg as long as possible, and this time will be recorded.
  • You will complete a grip strength test. You will grip a small device in 1 hand and squeeze as hard as you can while you are in a seated position. You will perform this test 3 times and your best measurement will be recorded. There will be no rest period between the 3 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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

Inclusion Criteria:

  1. Patients must have the ability to understand and willingness to sign a written informed consent document.
  2. Patients must be able to ambulate with or without an assistive device, without assistance from a person.
  3. Patients must be 65 years old or older.
  4. Patients must have a diagnosis of prostate cancer
  5. 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.
  6. Patients have received chemotherapy within last month.
  7. Patients must speak English.

Exclusion Criteria:

  1. Patients who decline to participate or who are determined incapable of completing the study.
  2. Active Central Nervous System (CNS) disease such as clinically-evident CNS metastases or leptomeningeal disease, dementia, or encephalopathy (per treating physician's assessment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire + Fall Risk Assessment
Physical Function Interview + Physical Function Tests + Symptom Assessment Interview
Behavioral: Interview
Physical Function and Symptom Assessment Interviews
Other Names:
  • survey
Other: Physical Function Tests
3 physical function tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number Patient Falls + Activity Limitations Using Functional Tests
Time Frame: 45 minutes total to complete during already-scheduled clinic visit
45 minutes total to complete during already-scheduled clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ying Guo, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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