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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


N/A
65 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number Patient Falls + Activity Limitations Using Functional Tests

Outcome Time Frame:

45 minutes total to complete during already-scheduled clinic visit

Safety Issue:

No

Principal Investigator

Ying Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0779

NCT ID:

NCT00836238

Start Date:

February 2009

Completion Date:

June 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Neural Functioning Assessment
  • Physical Assessment
  • Questionnaire
  • Objective Measures of Functional Status
  • Physical Function
  • Symptom Assessment Interview
  • Elderly
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030