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Completed

NCT Number: NCT02737839

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.

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Key information

Conditions

Geriatric Disorder Cancer Neoplasms Patient Fall

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stepping On Education Program

Other

Home visit

Other

patient questionnaire

Other

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

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.

Other names: Mini-BESTest

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.

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.

Primary outcomes

  1. Percent of participants who completed the 7 education sessions

    Time frame: 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 outcomes

  1. Percent of participants consented among approached potential participants

    Time frame: Completion of accrual (approximately 18 months)

    -The Pilot Waves will only be looked at for this outcome measure

  2. Fall rate during participation

    Time frame: Completion of participation (approximately 20 weeks)

    -The Pilot Waves will only be looked at for this outcome measure

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

    Time frame: Completion of participation (approximately 20 weeks)

    -The Pilot Waves will only be looked at for this outcome measure

  4. Behavior change intention in preventing falls

    Time frame: 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.

  5. Change in Pain Patient Reported Outcome (PRO)

    Time frame: 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

  6. Measure changes in balance waves

    Time frame: Baseline and 1 month after completion of participation (approximately 20 weeks)

    -The Gait & Balance Waves will only be looked at for this outcome measure

  7. Measure changes in gait waves

    Time frame: Baseline and 1 month after completion of participation (approximately 20 weeks)

    -The Gait & Balance Waves will only be looked at for this outcome measure

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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