Optimizing Fall-risk Prediction in Older Adults With Cancer

Study Overview
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Brief Summary
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To establish the optimal strategy of fall-risk assessment to predict falls in older adults receiving cancer therapy.

Official Title
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Optimizing Fall-risk Prediction in Older Adults With Cancer

Conditions
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Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥65 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: Unable to read and understand English

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fall Risk Assessment Group<br>-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<br>* 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<br>Other: Baseline Healthcare Provider Assessment<br>* 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.<br>Other: Follow-up Participant Assessment<br>* 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<br>Other: Follow-up Healthcare Provider Assessment<br>* 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.<br>Other: End-of-study Participant Assessment<br>* 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<br>Other: End-of-study Healthcare Provider Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls | -The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fall event |  | Up to 6 months | 
| Overall survival |  | Up to 6 months | 
| Number of falls that were considered injurious falls |  | 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) | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatric assessment