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Optimizing Fall-risk Prediction in Older Adults With Cancer

Optimizing Fall-risk Prediction in Older Adults With Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912273
Enrollment
227
Registered
2016-09-23
Start date
2016-10-12
Completion date
2020-01-09
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Geriatric assessment

Brief summary

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

Interventions

OTHERBaseline 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

OTHERBaseline 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.

OTHERFollow-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

OTHERFollow-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.

OTHEREnd-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

OTHEREnd-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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of fallsUp to 6 months-The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used

Secondary

MeasureTime frameDescription
Time to fall eventUp to 6 months
Overall survivalUp to 6 months
Number of falls that were considered injurious fallsUp to 6 months
Fear of falling as Measured by the Falls Efficacy Scale-InternationalUp to 6 monthsmeasures 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026