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

The Washington University

Status: Completed

Conditions: Patient Fall; Cancer; Geriatric Disorder

Treatments: Other: Stepping On Education Program; Other: Mini-Balance Evaluation Systems Test; Other: Patient Questionnaire; Other: Precise measure of movement testing; Other: Home visit; Other: GAITRite

Study type: Interventional

Funder types: Other

Identifiers

NCT02737839

201603069

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Arm 1: STEPPING ON

Experimental group

Description:

* 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

Treatment:

Other: Patient Questionnaire

Other: Stepping On Education Program

Other: GAITRite

Other: Precise measure of movement testing

Other: Home visit

Other: Mini-Balance Evaluation Systems Test