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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737839
• Other study ID #: 201603069
• Status: Completed
• Phase: N/A
• Start date: June 9, 2016
• Est. completion date: January 14, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Geriatric Disorder
• Patient Fall

Intervention

Other:
• Stepping On Education Program

• Home visit

• Patient Questionnaire
-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy
• Mini-Balance Evaluation Systems Test
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.
• GAITRite
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.
• Precise 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.

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	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	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)
Secondary	Fall rate during participation	-The Pilot Waves will only be looked at for this outcome measure	Completion of participation (approximately 20 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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