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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Geriatric Disorder; Patient Fall
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1: STEPPING ON; 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 & balanceComplete 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 neuropathy7 week STEPPING ON program is multi-component learning environment which has shown to help reduce fallsA home visit to gather any feedback on the experience of the programFollow-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; Other: Home visit; Other: Patient Questionnaire; -Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy; Other: 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.; Other Names: Mini-BESTest; Other: 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.; Other: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Katherine Clifton, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2016
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 10, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 201603069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No