ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02737839
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Geriatric Disorder Cancer Patient Fall 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 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
Actual Study Start Date : June 9, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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 & 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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737839


Contacts
Contact: Tanya Wildes, MD, MSCI 314-747-7510 twildes@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tanya Wildes, MD, MSCI    314-747-7510    twildes@wustl.edu   
Principal Investigator: Tanya Wildes, MD, MSCI         
Sub-Investigator: Aimee James, Ph.D.         
Sub-Investigator: Susan Stark, Ph.D.         
Sub-Investigator: Marian Keglovits, O.T.         
Sub-Investigator: Emily Somerville, O.T.         
Sub-Investigator: Andrea Hagemann, M.D.         
Sub-Investigator: Gammon Earhart, Ph.D.         
Sub-Investigator: Ryan Duncan, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tanya Wildes, MD, MSCI Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02737839     History of Changes
Other Study ID Numbers: 201603069
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No