A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- CIPN Symptoms
研究概览
简要总结
The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is:
• Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN?
Participants in both study groups will be asked to:
• Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
Participants in the EX-CIPN group will be asked to:
- Complete an additional aassessment at 6-months post-intervention
- Complete a 10-week remote, individualized exercise program
- Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
- Wear a FitBit throughout the study to track physical activity and promote behaviour change
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •diagnosed with any type of cancer
- •received chemotherapy treatment as part of curative-intent therapy (no minimum dose)
- •>6 months following chemotherapy completion with no current plans for further chemotherapy
- •report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- •neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)
- •capable of ambulation and transfers (with or without gait/transfer aid) (ECOG score 0-2)
- •are able to communicate sufficiently in English to complete intervention, questionnaires, and consent
- •have access to and able to operate videoconferencing
排除标准
- •currently meeting all recommendations from the physical activity guidelines for cancer survivors
- •have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation
- •have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)
- •currently enrolled in other rehabilitation or exercise-based interventions
研究组 & 干预措施
Usual Care Control
This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)
EX-CIPN Exercise-based Intervention
This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
干预措施: EX-CIPN (Behavioral)
结局指标
主要结局
CIPN Symptoms
时间窗: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.
次要结局
- CIPN-related disability(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))
- Strength (Upper Body)(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))
- Strength (Lower Body)(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))
- Balance(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))
- Gait Speed(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))
- Aerobic Functional Capacity(Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks))