Optimizing Fall-risk Prediction in Older Adults With Cancer

NCT02912273 | Completed

• 1 other identifier: 201609049
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Geriatric assessment

Outcome Measures

Primary Outcomes (1)

• Number of falls

  -The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used

  Up to 6 months

Secondary Outcomes (4)

• 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

  Up to 6 months

Study Arms (1)

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.

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

Interventions

Baseline Participant Assessment OTHER

* 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

Fall Risk Assessment Group

Baseline Healthcare Provider Assessment OTHER

* 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.

Fall Risk Assessment Group

Follow-up Participant Assessment OTHER

* 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

Fall Risk Assessment Group

Follow-up Healthcare Provider Assessment OTHER

* 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.

Fall Risk Assessment Group

End-of-study Participant Assessment OTHER

* 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

Fall Risk Assessment Group

End-of-study Healthcare Provider Assessment OTHER

* 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.

Fall Risk Assessment Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults receiving systemic therapy at Siteman Cancer Center

You may qualify if:

• 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

You may not qualify if:

• Unable to read and understand English

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Katherine Clifton, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: October 12, 2016
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)