Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
研究概览
简要总结
The investigators propose to deliver a pilot randomized controlled trial to 40 women newly diagnosed with breast cancer and scheduled to undergo chemotherapy. The current objectives are: 1) to evaluate the preliminary efficacy of the prehabilitation physical activity (PA) intervention delivered by a physical therapist and 2) assess the intervention's feasibility, acceptability, and appropriateness. The long-term goal is to scale this intervention for implementation into the standard of cancer care to prevent, mitigate, and treat cancer-related cognitive decline (CRCD).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
时间窗: After completion of intervention (estimated to be 12 weeks)
The FIM measures the degree to which a participant feels an intervention is feasible to them. It ranges from 4-20, and higher scores indicate more feasibility. We will use a cutoff of 16 to indicate "feasible"
Changes in self-reported cognition function as measured by FACT-Cog
时间窗: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
The FACT-Cog examines a range of self-reported cognitive domains, including perceived cognitive impairment (PCI, range 0-71), perceived cognitive abilities (PCA, range 0-28), impact of cognitive impairment on quality of life (CogQOL, range 0-16), cognitive impairment perceived by others (CogOth, range 0-16), and a total cognitive functioning score (the sum of the other 4 subscales). Higher scores indicate fewer cognitive difficulties.
次要结局
- Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline Task switching(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)(After completion of intervention (estimated to be 12 weeks))
- Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed(After completion of intervention (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline N-back(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline Flanker(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Changes in objective measures of cognition function as measured by BrainBaseline Stroop(Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks))
- Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)(After completion of intervention (estimated to be 12 weeks))