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
- 1
- 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
- •Eligibility Criteria:
- •Diagnosis of breast cancer (stage I-III).
- •At least 18 years old.
- •Scheduled to receive curative-intent chemotherapy.
- •English speaking.
- •Deemed fit to participate in a PA intervention by their oncologist.
- •Not currently participating in another physical activity research study.
- •Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- 未提供
研究组 & 干预措施
Physical Activity Intervention
- Participants will complete a primarily home-based PA intervention, with the goal of safely increasing their steps/day by incorporating moderate-to-vigorous physical activity (MVPA)
- Participants will receive Fitbits with heart rate capabilities to support maintenance of the prescribed intensity during home exercise sessions and participants' self-monitoring of daily steps.
- Participants will strategize aerobic MVPA behaviors with the intervention PT to identify preferable and enjoyable PA modalities (e.g., walking, cycling), while also identifying alternative options to allow for flexibility if life- or cancer-specific barriers arise
- During the first Zoom coaching session, the intervention PT will train participants on using the Fitbit and completing home exercise logs. The PT will continue to meet with participants to support exercise maintenance, review home exercise sessions, strategize new exercises, and troubleshoot emerging chemotherapy-related health declines.
干预措施: Physical Activity Intervention (Other)
Usual care, wait-list control condition
-Participants in the control group will proceed with their treatment regimen as prescribed by their oncologist(s). To prevent drop out and high attrition rates as well as promote healthy behavior, control group participants will receive a Fitbit at the initial set-up meeting to wear during chemotherapy, as well as an individualized home exercise program and up to two Zoom coaching sessions with a PT after chemotherapy completion.
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))