NCT00836238

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

January 26, 2009

Last Update Submit

July 31, 2012

Conditions

Keywords

Prostate CancerNeural Functioning AssessmentPhysical AssessmentQuestionnaireObjective Measures of Functional StatusPhysical FunctionSymptom Assessment InterviewElderly

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

Behavioral: InterviewOther: Physical Function Tests

Interventions

InterviewBEHAVIORAL

Physical Function and Symptom Assessment Interviews

Also known as: survey
Questionnaire + Fall Risk Assessment

3 physical function tests.

Questionnaire + Fall Risk Assessment

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

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

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ying Guo, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations