Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy

Study Overview
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Brief Summary
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Chronic disease self-management is the ability of the individual, in conjunction with family, community and healthcare professionals to manage symptoms, treatments, lifestyle changes and psychosocial, cultural and spiritual consequences associated with a chronic condition. Self-management strategies have been successfully used in supportive care and survivorship in oncology. Stepping On, a multi-component program using a small-group learning environment, reduces falls by 31%. It empowers participants with knowledge about fall-risk, exercise, medications and environmental hazards to self-manage their risk of falls over 7 weeks of educational sessions, followed by a home visit. The research in this proposal will yield the adaptation of the effective group-education-based fall-prevention intervention Stepping On, tailored to cancer patients, feasible for testing in a multi-institutional trial, and ultimately scalable in the oncology setting.

Official Title
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Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy

Conditions
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Geriatric Disorder, Cancer, Patient Fall

Intervention / Treatment
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* Other: Stepping On Education Program
* Other: Home visit
* Other: Patient Questionnaire
* Other: Mini-Balance Evaluation Systems Test
* Other: GAITRite
* Other: Precise measure of movement testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Patient Participants: Age ≥70 years. Reports a fall within the past 1 year OR self-reports that they are concerned about falling. Receiving systemic cancer therapy (including conventional chemotherapy, novel/targeted agents, immunotherapy, monoclonal antibody therapy, oral tyrosine kinase inhibitors, or hormonal agents) OR will begin systemic therapy within the next 4 weeks. Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria for Patient Participants: Life expectancy <6 months. Unable to understand written or spoken English.

Ages Eligible for Study
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Minimum Age: 70 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: STEPPING ON<br>Adaptation Waves is to adapt Stepping On to the oncology setting/Pilot Waves is to determine the feasibility & acceptability of the program for older adults receiving cancer care/Gait & Balance Waves is to determine whether the participants experience changes in their gait & balance Complete baseline questionnaires about Instrumental Activities of Daily Living, Medical Outcome Study Activities, Karnofsky Performance Status, falls in past 3 months, medications, comorbidities, vision & hearing, The Falls Behavioral Scale, The Falls Efficacy Scale-International, Patient Reported Outcome pain, PRO neuropathy 7 week STEPPING ON program is multi-component learning environment which has shown to help reduce falls A home visit to gather any feedback on the experience of the program Follow-up questionnaires up to 3 months after completion of the program Participants may elect to participate in a booster session to reinforce concepts 3-6 months after completion of the program | Other: Stepping On Education Program<br> <br> Other: Home visit<br> <br> Other: Patient Questionnaire<br>* -Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy<br>Other: Mini-Balance Evaluation Systems Test<br>* The Mini-BESTest includes 14-items that assess balance across four domains: 1) anticipatory postural adjustments, 2) reactive postural responses, 3) sensory orientation, and 4) stability in gait. Each item is rated on a 0-2 scale with 0 indicating poor balance and 2 indicating no impairment. The total possible score on the Mini-BESTest is 28 points Balance testing will take approximately 15 minutes.<br>* Other names: Mini-BESTest;Other: GAITRite<br>* Gait will be assessed using the 4.87-m GAITRite The GAITRite is a computerized mat that allows for measurement of spatiotemporal measures (e.g., gait velocity, stride length) of gait. We will measure gait in the following conditions: 1) comfortable forward, 2) fast-as-possible, and 3) dual-task. For comfortable forward, participants will be asked to walk at their self-perceived normal pace. For fast-as-possible, participants will be asked to walk as quickly and safely as possible. For dual-task, participants will be asked to walk at their comfortable pace forward while saying as many words that begin with a letter given to them just prior to the start of the trial. Participants will complete five trials of each condition. Gait testing will take approximately 15 minutes.<br>Other: Precise measure of movement testing<br>* We will conduct additional movement-based testing with participants wearing small, portable sensors (APDM, Inc., Portland, OR). These sensors allow for precise measurement of movement characteristics. The sensors will be worn on the outside of clothing and will be placed on the following body locations: 1) sternum, 2) low back, 3) right wrist, 4) left wrist, 5) right ankle, and 6) left ankle. The participants will wear these sensors during the following movement tasks: 1) Two Minute Walk Test, 2) Timed Up & Go, 3) Dual Timed Up & Go, 4) Stand and Walk (SAW), and 5) 360 Degree Turn test. These sensors will allow for capture of precise measures postural sway, arm swing, gait variability, and many other variables the proposed movement tasks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants who completed the 7 education sessions | -The Pilot Waves will only be looked at for this outcome measure | Completion of all participants in the Pilot Wave groups (approximately 85 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants consented among approached potential participants | -The Pilot Waves will only be looked at for this outcome measure | Completion of accrual (approximately 18 months) | 
| Fall rate during participation | -The Pilot Waves will only be looked at for this outcome measure | Completion of participation (approximately 20 weeks) | 
| Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling | -The Pilot Waves will only be looked at for this outcome measure | Completion of participation (approximately 20 weeks) | 
| Behavior change intention in preventing falls | The Pilot Waves will only be looked at for this outcome measure To measure behavior change intention in preventing falls the participant will be asked 24 questions about how they prevent falls. Answers to choose from include never, sometimes, often, always, or does not apply. | Completion of participation (approximately 20 weeks) | 
| Change in Pain Patient Reported Outcome (PRO) | -5 questions to ask participant about their pain levels and how the pain interfered with their daily lives, answers range from not at all to very much | Completion of participation (approximately 20 weeks) | 
| Measure changes in balance waves | -The Gait & Balance Waves will only be looked at for this outcome measure | Baseline and 1 month after completion of participation (approximately 20 weeks) | 
| Measure changes in gait waves | -The Gait & Balance Waves will only be looked at for this outcome measure | Baseline and 1 month after completion of participation (approximately 20 weeks) |