Optimizing Fall-risk Prediction in Older Adults With Cancer

Cancer Clinical Trial

Official title:

Optimizing Fall-risk Prediction in Older Adults With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912273
• Other study ID #: 201609049
• Status: Completed
• Start date: October 12, 2016
• Est. completion date: January 9, 2020

Study information

• Verified date: October 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of falls	-The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used	Up to 6 months
Secondary	Time to fall event		Up to 6 months
Secondary	Overall survival		Up to 6 months
Secondary	Number of falls that were considered injurious falls		Up to 6 months
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine