Does Cognitive Rehabilitation and Physical Activity Impact Executive Functioning Following Radiation Therapy for Cerebral Metastases? A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Percentage of Cognitive Therapy intervention tasks.
研究概览
简要总结
To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.
详细描述
Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical & cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
All participants will be blinded to the study design and will be randomized into one of three treatment arms. Research assistant is blinded to both the study design and to which arm the participants are randomized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A potential subject must meet all of the following inclusion criteria to be eligible to participate in the study:
- •Ability to understand and the willingness to provide written informed consent
- •18 years of age and older
- •Diagnosed with one or more metastatic brain tumor(s)
- •Medical treatment plan includes whole-brain radiation therapy and / or sterotactic radiosurgery
排除标准
- •A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- •Diagnosis of dementia or unable to grant their own informed consent
- •Prisoner or patient in custody
- •Patient on psychiatric hold
- •Physically unable to participate in the study
- •The opinion of the treating physician determines it is not medically safe to participate in the study
- •Pre-registration screen of cognition is "severe" or lower.
研究组 & 干预措施
Arm 1: Physical activity intervention
Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 1: intervention of physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.
干预措施: Physical Activity (Behavioral)
Arm 2:Physical activity and cognitive intervention
Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.
干预措施: Physical Activity (Behavioral)
Arm 2:Physical activity and cognitive intervention
Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.
干预措施: Cognitive rehabilitation (Behavioral)
Arm 3: Cognitive and begin physical activity intervention
Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.
干预措施: Physical Activity (Behavioral)
Arm 3: Cognitive and begin physical activity intervention
Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities.
干预措施: Cognitive rehabilitation (Behavioral)
结局指标
主要结局
Percentage of Cognitive Therapy intervention tasks.
时间窗: 18.5 months
Participant completed ≥ 80% of CR interventions (required \< 20% rest period during or between tasks).
Lengths of sessions completed.
时间窗: 18.5 months
Participant completed full scheduled minutes per session ≥ 80% of time.
Recruitment percentage of eligible subjects.
时间窗: 18.5 months
Recruitment: success defined as enrollment rate of 19% of eligible subjects.
Retention percentage of participants at end-of-study.
时间窗: 18.5 months
Retention: success defined as retention rate above 56% at end-of-study.
Percentage of completion of Physical Activity intervention tasks.
时间窗: 18.5 months
Participant completed ≥ 80% of PA interventions (required \< 20% rest period during or between tasks).
Non-attendance rates of participants. instructions.
时间窗: 18.5 months
Participant missed or cancelled therapy sessions less than 15% of time.
次要结局
- Change in cognitive abilities.(18.5 months)
- Change in physical abilities.(18.5 months)