Clinical trial NCT02737839: Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
Official title: Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Disorder
Cancer
Patient Fall
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 101
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Percent of participants who completed the 7 education sessions
timeFrame: Completion of all participants in the Pilot Wave groups (approximately 85 weeks)
Secondary outcomes:
measure: Percent of participants consented among approached potential participants
timeFrame: Completion of accrual (approximately 18 months)
measure: Fall rate during participation
timeFrame: Completion of participation (approximately 20 weeks)
measure: Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling
timeFrame: Completion of participation (approximately 20 weeks)
measure: Behavior change intention in preventing falls
timeFrame: Completion of participation (approximately 20 weeks)
measure: Change in Pain Patient Reported Outcome (PRO)
timeFrame: Completion of participation (approximately 20 weeks)
measure: Measure changes in balance waves
timeFrame: Baseline and 1 month after completion of participation (approximately 20 weeks)
measure: Measure changes in gait waves
timeFrame: Baseline and 1 month after completion of participation (approximately 20 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Katherine Clifton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: