Geriatric Disorder, Cancer, Patient Fall
Conditions
Brief summary
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.
Interventions
OTHERStepping On Education Program
OTHERHome visit
-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy
* 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.
OTHERGAITRite
* 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.
OTHERPrecise measure of movement testing
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants who completed the 7 education sessions | Completion of all participants in the Pilot Wave groups (approximately 85 weeks) | -The Pilot Waves will only be looked at for this outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants consented among approached potential participants | Completion of accrual (approximately 18 months) | -The Pilot Waves will only be looked at for this outcome measure |
| Fall rate during participation | Completion of participation (approximately 20 weeks) | -The Pilot Waves will only be looked at for this outcome measure |
| Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling | Completion of participation (approximately 20 weeks) | -The Pilot Waves will only be looked at for this outcome measure |
| Change in Pain Patient Reported Outcome (PRO) | Completion of participation (approximately 20 weeks) | -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 |
| Measure changes in balance waves | Baseline and 1 month after completion of participation (approximately 20 weeks) | -The Gait & Balance Waves will only be looked at for this outcome measure |
| Measure changes in gait waves | Baseline and 1 month after completion of participation (approximately 20 weeks) | -The Gait & Balance Waves will only be looked at for this outcome measure |
| Behavior change intention in preventing falls | Completion of participation (approximately 20 weeks) | * 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. |
Countries
United States
Outcome results
None listed