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

October 13, 2020 updated by: Washington University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 & 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
-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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Completion of all participants in the Pilot Wave groups (approximately 85 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Completion of accrual (approximately 18 months)
Fall rate during participation
Time Frame: Completion of participation (approximately 20 weeks)
-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
Time Frame: Completion of participation (approximately 20 weeks)
-The Pilot Waves will only be looked at for this outcome measure
Completion of participation (approximately 20 weeks)
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.
Completion of participation (approximately 20 weeks)
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
Completion of participation (approximately 20 weeks)
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
Baseline and 1 month after completion of participation (approximately 20 weeks)
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
Baseline and 1 month after completion of participation (approximately 20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Clifton, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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