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

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ClinicalTrials.gov Identifier: NCT02737839
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : July 9, 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 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

    • 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
    • After completion of program, a home visit to gather any feedback on the experience of the program
    • Follow-up questionnaires will be completed either at the home visit or returned via mail up to 3 months after completion of the program
  • Participants may elect to participate in a "booster session" to reinforce concepts in the program 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




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



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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 314-454-8681 twildes@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tanya Wildes, MD, MSCI    314-454-8681    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.         
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: July 9, 2018
Last Verified: July 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