Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Percent of participants who completed the 7 education sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •for Patient Participants:
- •Life expectancy <6 months.
- •Unable to understand written or spoken English.
研究组 & 干预措施
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/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
干预措施: Stepping On Education Program (Other)
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/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
干预措施: Home visit (Other)
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/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
干预措施: Patient Questionnaire (Other)
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/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
干预措施: Mini-Balance Evaluation Systems Test (Other)
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/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
干预措施: GAITRite (Other)
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/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
干预措施: Precise measure of movement testing (Other)
结局指标
主要结局
Percent of participants who completed the 7 education sessions
时间窗: Completion of all participants in the Pilot Wave groups (approximately 85 weeks)
-The Pilot Waves will only be looked at for this outcome measure
次要结局
- Percent of participants consented among approached potential participants(Completion of accrual (approximately 18 months))
- Behavior change intention in preventing falls(Completion of participation (approximately 20 weeks))
- Fall rate during participation(Completion of participation (approximately 20 weeks))
- Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling(Completion of participation (approximately 20 weeks))
- Change in Pain Patient Reported Outcome (PRO)(Completion of participation (approximately 20 weeks))
- Measure changes in balance waves(Baseline and 1 month after completion of participation (approximately 20 weeks))
- Measure changes in gait waves(Baseline and 1 month after completion of participation (approximately 20 weeks))