Questionnaire and Fall Risk Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00836238
First received: January 26, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.

Condition Intervention
Prostate Cancer
Behavioral: Interview
Other: Physical Function Tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire + Fall Risk Assessment
Physical Function Interview + Physical Function Tests + Symptom Assessment Interview
Behavioral: Interview
Physical Function and Symptom Assessment Interviews
Other Name: survey
Other: Physical Function Tests
3 physical function tests.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836238

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ying Guo, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00836238     History of Changes
Other Study ID Numbers: 2008-0779
Study First Received: January 26, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Neural Functioning Assessment
Physical Assessment
Questionnaire
Objective Measures of Functional Status
Physical Function
Symptom Assessment Interview
Elderly

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014