An observational study in Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Washington University School of Medicine · Observational
To establish the optimal strategy of fall-risk assessment to predict falls in older adults receiving cancer therapy.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Older adults receiving systemic therapy at Siteman Cancer Center
Exclusion Criteria:
-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.
Other: Baseline Participant Assessment · Other: Baseline Healthcare Provider Assessment · Other: Follow-up Participant Assessment · Other: Follow-up Healthcare Provider Assessment · Other: End-of-study Participant Assessment · Other: End-of-study Healthcare Provider 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
* 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.
* 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
* 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.
* 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
* 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.
Number of falls
-The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used
Time frame: Up to 6 months
Time to fall event
Time frame: Up to 6 months
Overall survival
Time frame: Up to 6 months
Number of falls that were considered injurious falls
Time frame: Up to 6 months
Fear of falling as Measured by the Falls Efficacy Scale-International
measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned)
Time frame: Up to 6 months
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine