Falls Risk Questionnaire in Older Adults With Cancer
April 27, 2017 updated by: Washington University School of Medicine
Pilot Study of the Falls Risk Questionnaire in Older Adults With Cancer
The purpose of this research study is to look at the use of a series of questionnaires evaluating risk for falls in order to collect information that might be used to develop a larger study aiming to recognize who is more at risk for falls and how to best intervene to prevent falls in older adults with cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
21
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
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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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
All
Sampling Method
Non-Probability Sample
Study Population
Cancer patients aged 65 years of age or older
Description
Inclusion Criteria:
- Age 65 or older; 5 patients will be enrolled in each of the following age cohorts: 65-69, 70-74, 75-79, 80 and older
- Diagnosis of cancer, any type
- Currently receiving or anticipated to initiate systemic cancer therapy within 1 month, including endocrine therapy, chemotherapy or targeted therapies
- Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria:
- Unable to understand written English
- Psychiatric illness/social situation that would limit compliance with the study requirements
- Unable to walk.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Completion of Questionnaires
Participants will complete an assessment consisting of the Falls Risk Questionnaire, a primarily self-administered geriatric assessment (GA) developed by the Cancer and Aging Research Group, a quality of life scale (FACT GOG/NTX) and the Falls Efficacy Scale-International. Each questionnaire contains approximately 150 questions and will take between 30 minutes and one hour to complete. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients
Time Frame: Day 1
|
The percent of patients who complete the assessment will be calculated.
Successful completion will be defined as the completion of all items on the questionnaires.
If more than 85% of subjects are able to complete the FRQ and CARG GA, the assessment will be deemed feasible.
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to completion of FRQ and CARG GA of enrolled patients
Time Frame: Day 1
|
Day 1
|
|
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Satisfaction with the questionnaires
Time Frame: Day 1
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We will calculate the frequency of participant feedback that 1) certain questions that were difficult to understand 2) the questionnaire was too short or too long 3) questions were upsetting or 4) the questionnaire left out important questions to ask.
Open-ended follow-up questions in which the participants will be given the opportunity to write out their responses will be examined qualitatively for recurring themes of particular questions that were unsatisfactory
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Day 1
|
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Psychological consequences of falling
Time Frame: Day 1
|
Uses the Falls Efficacy Scale-International (FES-I) and Health Related Quality of Life (HRQOL) using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)
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Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tanya Wildes, M.D., M.S.C.I., Washington University School of Medicine
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.
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
August 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
July 23, 2014
First Submitted That Met QC Criteria
July 28, 2014
First Posted (Estimate)
July 30, 2014
Study Record Updates
Last Update Posted (Actual)
May 1, 2017
Last Update Submitted That Met QC Criteria
April 27, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 201407080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.