Prostate CancerNCT00836238
Questionnaire and Fall Risk Assessment
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Interview and Physical Function Tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Interview, Physical Function Tests
- Keywords
- Prostate Cancer, Neural Functioning Assessment, Physical Assessment, Questionnaire, Objective Measures of Functional Status, Physical Function, Symptom Assessment Interview, Elderly
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Also called survey
Physical Function and Symptom Assessment Interviews
Physical Function TestsOther
3 physical function tests.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire + Fall Risk Assessment | Physical Function Interview + Physical Function Tests + Symptom Assessment Interview Receives: Behavioral: Interview; Other: Physical Function Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Patient Falls + Activity Limitations Using Functional Tests
Measured: 45 minutes total to complete during already-scheduled clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Guo, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836238
- Sponsor's protocol ID
- 2008-0779
- Status last verified
- Jul 2012
- First submitted
- 26 Jan 2009
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00836238
- Acronym / sponsor ID
- 2008-0779
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Neural Functioning Assessment, Physical Assessment, Questionnaire, Objective Measures of Functional Status, Physical Function, Symptom Assessment Interview, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire + Fall Risk Assessment | – | Behavioral: Interview, Other: Physical Function TestsPhysical Function Interview + Physical Function Tests + Symptom Assessment Interview |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAlso: surveyPhysical Function and Symptom Assessment Interviews | Behavioural | Questionnaire + Fall Risk Assessment |
| Physical Function Tests3 physical function tests. | Other | Questionnaire + Fall Risk Assessment |
Primary outcome
Number Patient Falls + Activity Limitations Using Functional Tests
Time frame: 45 minutes total to complete during already-scheduled clinic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Guo, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Patient Falls + Activity Limitations Using Functional Tests (time frame: 45 minutes total to complete during already-scheduled clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.