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

NCT02737839 | Completed

• 1 other identifier: 201603069
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Disorder; Cancer; Patient Fall

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent of participants consented among approached potential participants

  Completion of accrual (approximately 18 months)

• Fall rate during participation

  Completion of participation (approximately 20 weeks)

• Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling

  Completion of participation (approximately 20 weeks)

• Behavior change intention in preventing falls

  Completion of participation (approximately 20 weeks)

• Change in Pain Patient Reported Outcome (PRO)

  Completion of participation (approximately 20 weeks)

Study Arms (1)

Arm 1: STEPPING ON

EXPERIMENTAL

* 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; Other: Home visit; Other: Patient Questionnaire; Other: Mini-Balance Evaluation Systems Test; Other: GAITRite; Other: Precise measure of movement testing

Interventions

Stepping On Education Program OTHER

Arm 1: STEPPING ON

Home visit OTHER

Arm 1: STEPPING ON

Patient Questionnaire OTHER

-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy

Arm 1: STEPPING ON

Mini-Balance Evaluation Systems Test OTHER

* 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.

Also known as: Mini-BESTest

Arm 1: STEPPING ON

GAITRite OTHER

* 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.

Arm 1: STEPPING ON

Precise measure of movement testing OTHER

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.

Arm 1: STEPPING ON

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Life expectancy \<6 months.
• Unable to understand written or spoken English.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

House Calls; Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Katherine Clifton, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 14, 2016
• Study Start: June 9, 2016
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)