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

Not Applicable

Completed

• Conditions: Cancer; Patient Fall; Geriatric Disorder

• Registration Number: NCT02737839
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-10
• Study First Posted: 2016-04-14
• Study Start: 2016-06-09
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of participants who completed the 7 education sessions	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

Name	Time	Method
Percent of participants consented among approached potential participants	Completion of accrual (approximately 18 months)	-The Pilot Waves will only be looked at for this outcome measure
Fall rate during participation	Completion of participation (approximately 20 weeks)	-The Pilot Waves will only be looked at for this outcome measure
Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling	Completion of participation (approximately 20 weeks)	-The Pilot Waves will only be looked at for this outcome measure
Behavior change intention in preventing falls	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.
Change in Pain Patient Reported Outcome (PRO)	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
Measure changes in balance waves	Baseline and 1 month after completion of participation (approximately 20 weeks)	-The Gait \& Balance Waves will only be looked at for this outcome measure
Measure changes in gait waves	Baseline and 1 month after completion of participation (approximately 20 weeks)	-The Gait \& Balance Waves will only be looked at for this outcome measure

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States