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

Not Applicable

Completed

• Conditions: Cancer; Patient Fall; Geriatric Disorder
• Interventions: 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

• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: STEPPING ON	Home visit	* 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
Arm 1: STEPPING ON	Mini-Balance Evaluation Systems Test	* 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
Arm 1: STEPPING ON	Precise measure of movement testing	* 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
Arm 1: STEPPING ON	Stepping On Education Program	* 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
Arm 1: STEPPING ON	Patient Questionnaire	* 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
Arm 1: STEPPING ON	GAITRite	* 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

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