Optimizing Fall-risk Prediction in Older Adults With Cancer

Completed

• Conditions: Cancer
• Interventions: 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

• Registration Number: NCT02912273
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Study Start: 2016-10-12
• Primary Completion: 2020-01-09
• Study Completion: 2020-01-09
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Read More

Exclusion Criteria

• Unable to read and understand English

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fall Risk Assessment Group	End-of-study Healthcare Provider Assessment	-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.
Fall Risk Assessment Group	Baseline Healthcare Provider Assessment	-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.
Fall Risk Assessment Group	Follow-up Participant Assessment	-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.
Fall Risk Assessment Group	Follow-up Healthcare Provider Assessment	-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.
Fall Risk Assessment Group	Baseline Participant Assessment	-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.
Fall Risk Assessment Group	End-of-study Participant Assessment	-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.

Primary Outcome Measures

Name	Time	Method
Number of falls	Up to 6 months	-The Prevention of Falls Network Europe (PROFANE) Consensus Group guidelines will be used

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 6 months
Time to fall event	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	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)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States