Optimizing Fall-risk Prediction in Older Adults With Cancer
NCT ID: NCT02912273
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
227 participants
OBSERVATIONAL
2016-10-12
2020-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fall Risk Assessment Group
-Participants will complete baseline primarily self-administered cancer-specific geriatric assessments and measures of neuropathy and pain, an abbreviated geriatric assessment with each follow-up clinic visit (generally every 3-4 weeks in patients receiving systemic therapy) for 6-months of follow-up and a final end-of-study assessment.
Baseline Participant Assessment
* Section 1 contains demographic questions
* Section 2 contains daily activity questions with multiple choice answers, multiple physical function questions, and if the participants has fallen and how many falls have occurred in the last 6 months
* Section 3 has the participant list all medication
* Section 4 contains several questions about participant health (lists of illnesses and indicate if illness interferes with their activities)
* Section 5 contains several questions about participant fall concerns with answers ranging from 1=Not at all to 4=Very
* Section 6 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
Baseline Healthcare Provider Assessment
* Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Follow-up Participant Assessment
* Section 1 contains multiple choice questions about daily actives and several physical function questions
* Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
* Section 3 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
Follow-up Healthcare Provider Assessment
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
End-of-study Participant Assessment
* Section 1 contains multiple choice questions about daily actives and several physical function questions
* Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
* Section 3 contains multiple questions about the participant's concern about falling with answers ranging from 1=Not at all to 4=Very
* Section 4 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
End-of-study Healthcare Provider Assessment
* Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Interventions
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Baseline Participant Assessment
* Section 1 contains demographic questions
* Section 2 contains daily activity questions with multiple choice answers, multiple physical function questions, and if the participants has fallen and how many falls have occurred in the last 6 months
* Section 3 has the participant list all medication
* Section 4 contains several questions about participant health (lists of illnesses and indicate if illness interferes with their activities)
* Section 5 contains several questions about participant fall concerns with answers ranging from 1=Not at all to 4=Very
* Section 6 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
Baseline Healthcare Provider Assessment
* Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Follow-up Participant Assessment
* Section 1 contains multiple choice questions about daily actives and several physical function questions
* Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
* Section 3 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
Follow-up Healthcare Provider Assessment
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
End-of-study Participant Assessment
* Section 1 contains multiple choice questions about daily actives and several physical function questions
* Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
* Section 3 contains multiple questions about the participant's concern about falling with answers ranging from 1=Not at all to 4=Very
* Section 4 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling
End-of-study Healthcare Provider Assessment
* Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
* Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
* Timed "Up and "Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Eligibility Criteria
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Inclusion Criteria
* Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents or hormonal agents (e.g. anti-estrogen or anti-androgen) OR will begin systemic therapy within the next 4 weeks.
* Estimated life expectancy \>1 year
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Katherine Clifton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201609049
Identifier Type: -
Identifier Source: org_study_id
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