Geriatric DisorderNCT02737839
Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
A study testing Stepping On Education Program, Home visit and Patient Questionnaire in people with Geriatric Disorder and Cancer, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Disorder, Cancer, Patient Fall
- What is being tested?
- Stepping On Education Program, Home visit and Patient Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2016to 14 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Life expectancy <6 months.
- Unable to understand written or spoken English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Stepping On Education Program, Home visit, Patient Questionnaire, Mini-Balance Evaluation Systems Test, GAITRite
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping On Education ProgramOther
Home visitOther
Patient QuestionnaireOther
-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy
Mini-Balance Evaluation Systems TestOther
Also called Mini-BESTest
- 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.
GAITRiteOther
- 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 testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who completed the 7 education sessions
-The Pilot Waves will only be looked at for this outcome measure
Measured: Completion of all participants in the Pilot Wave groups (approximately 85 weeks)
Secondary outcomes (7)
Percent of participants consented among approached potential participants
-The Pilot Waves will only be looked at for this outcome measure
Measured: Completion of accrual (approximately 18 months)
Fall rate during participation
-The Pilot Waves will only be looked at for this outcome measure
Measured: 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
Measured: 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.
Measured: 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
Measured: Completion of participation (approximately 20 weeks)
Measure changes in balance waves
-The Gait \& Balance Waves will only be looked at for this outcome measure
Measured: 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
Measured: Baseline and 1 month after completion of participation (approximately 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start9 Jun 2016
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Clifton, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737839
- Sponsor's protocol ID
- 201603069
- Status last verified
- Oct 2020
- First submitted
- 22 Mar 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
- ClinicalTrials.gov ID
- NCT02737839
- Acronym / sponsor ID
- 201603069
- Conditions
- Geriatric Disorder, Cancer, Patient Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Jun 2016 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: STEPPING ON | Experimental | 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* 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Life expectancy <6 months.
- Unable to understand written or spoken English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepping On Education Program | Other | Arm 1: STEPPING ON |
| Home visit | Other | Arm 1: STEPPING ON |
| Patient Questionnaire-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy | Other | Arm 1: STEPPING ON |
| Mini-Balance Evaluation Systems TestAlso: Mini-BESTest* 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 | Arm 1: STEPPING ON |
| 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 | Arm 1: STEPPING ON |
| Precise measure of movement testingWe 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. | Other | Arm 1: STEPPING ON |
Primary outcome
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
7 secondary outcomes
Percent of participants consented among approached potential participants
Time frame: Completion of accrual (approximately 18 months)
Fall rate during participation
Time frame: 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)
Behavior change intention in preventing falls
Time frame: Completion of participation (approximately 20 weeks)
Change in Pain Patient Reported Outcome (PRO)
Time frame: Completion of participation (approximately 20 weeks)
Measure changes in balance waves
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Clifton, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepping On Education Program, Home visit and Patient Questionnaire in people with Geriatric Disorder and Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who completed the 7 education sessions (time frame: Completion of all participants in the Pilot Wave groups (approximately 85 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.