ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. The study aims are:
- To evaluate the clinical effectiveness of a 10-week EA regimen targeting neuropsychiatric-related acupoints in reducing cognitive toxicity among cancer survivors in Singapore.
- To explore the biological mechanisms underlying EA's effects on cognitive function.
- To assess the early implementation of EA for managing cognitive toxicity in cancer survivors.
Researchers will compare results from the true EA arm, sham EA arm and waitlist control arm, to see if electroacupuncture can help improve cognitive issues related to cancer and its treatment, how it may work, and what factors may affect how it is delivered in cancer care.
Participants will:
- Be assigned to either of the 3 arms (true EA, sham EA, waitlist control)
- Received 10 EA sessions (if assigned to true or sham EA arm)
- Complete 3 study assessment visits at baseline, Week 13, and Week 17
- Be invited to a one-time interview to share their study experience (optional, if selected)
详细描述
Electroacupuncture (EA) is a promising, emerging intervention to manage cognitive toxicity among patients with cancer. The primary goal of the EAST-ALIGN study is to evaluate the clinical effectiveness and understand the biological mechanisms of EA in reducing cognitive toxicity among cancer survivors through a randomized, blinded sham and waitlist controlled, clinical trial. Simultaneously, the investigators will collect implementation data on engaging community Traditional Chinese Medicine (TCM) practitioners to deliver EA. This approach facilitates the early identification and resolution of implementation barriers, accelerating EA adoption into clinical practice if proven effective.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Survivor participants
- •Aged 21-85 years
- •Documented cancer diagnosis in electronic health records
- •Perceived by the survivor or oncology care provider that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
- •Able to understand English or Mandarin
- •Able to provide informed consent
- •Stakeholder participants
- •Aged ≥21 years
- •Identified as having a relevant role, experience, or perspective relating to the delivery, referral, coordination, or implementation of EA or supportive cancer care in the study context
- •Able to provide informed consent
排除标准
- •Survivor participants
- •Presence of brain metastases
- •Severe needle phobia
- •Known bleeding disorder (e.g. hemophilia, von Willebrand disease, thrombocytopenia).
- •Current use of antiplatelet or anticoagulant therapy (e.g. aspirin, clopidogrel, warfarin, enoxaparin, rivaroxaban, dabigatran)
- •Known blood-borne communicable disease (e.g. hepatitis B, hepatitis C, human immunodeficiency virus)
- •Presence of a pacemaker or other electronic implant, or a history of epilepsy
- •Current acupuncture treatment or acupuncture received within the past 3 months
- •Current pregnancy, planned pregnancy over the next 5 months, or breastfeeding.
- •Incapable of providing informed consent
- •Unable to complete study procedures
- •Stakeholder participants
- •Incapable of providing informed consent
- •Unable to complete study procedures