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临床试验/NCT01569269
NCT01569269已完成不适用

A Randomized, Four-Arm Study Comparing Reiki, Yoga, Meditation, or Patient Education Group for Addressing Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

George Mason University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
FACT GOG-ntx scale

研究概览

简要总结

The purpose of this study is to test whether people with symptoms of chemotherapy-induced peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in a six-week Reiki, Yoga, Meditation, or Educational experience.

详细描述

Chemotherapy-induced peripheral neuropathy (CIPN) is a side effect that occurs with many of the most common chemotherapeutic agents used to treat cancer. Typically, CIPN is experienced as tingling, burning, numbness, or pain in the upper and lower extremities and other parts of the body. Severity of symptoms can range from bothersome to disabling and can have profoundly negative effects on quality of life. Although the specific incidence or prevalence of CIPN is unknown, it is generally estimated at 30 to 40 percent in patients who have received the classes of chemotherapeutic agents used to treat breast, colon, and lung, cancers, and lymphomas. There are no treatments or drugs that consistently ameliorate or lead to the reversal of CIPN symptoms.Typically, symptoms of CIPN are considered along with other pain symptoms and treated with opioids and analgesics. Additionally, the prescription of anticonvulsant medications and tricyclic antidepressants can help alleviate neuropathic pain. While these strategies can provide relief from cancer-related pain, they often yield limited results for symptoms of CIPN. With few allopathic treatment alternatives for attenuating the symptoms of CIPN, people living with these symptoms have few options other than to endure them.

Unlike treatments based upon nociceptive and neuropathic models of pain that regard the pain response as the outcome of a finite and mechanistic chain of biochemical events, complementary treatments acknowledge the interpenetrating nature of the relationships between body, mind, and spirit. Typically, complementary or integrative health strategies incorporate psychological, emotional, and spiritual elements along with biochemical strategies when addressing pain. Of particular interest in the proposed pilot study are complementary techniques that include Yoga, Meditation, and Reiki.

Utilizing a pretest-posttest control group design with random assignment, this four-arm experimental pilot study will be undertaken to determine the feasibility of three complementary approaches in reducing the signs and symptoms of CIPN. This design was chosen for its ability to support causal inference while managing threats to internal and external design validity. The use of random assignment in the development of intervention and comparison groups will strengthen the ability of this design to manage threats to internal validity more efficiently. This pilot study involves the collection of quantitative data from self-administered instruments that have been designed to measure health related quality of life, symptoms of neurotoxicity, psychological distress, and mindfulness.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants must be of at least 18 years of age,
  • participants must have persistent symptoms of CIPN resulting from treatment with vinca alkaloid, taxane, platinum class chemotherapies or immunomodulators (Thalidomide) or antineoplastic agents (Velcade) for a known cancer diagnosis
  • participants must have completed chemotherapy at least three months prior to beginning the study,
  • participants cannot concurrently receive chemotherapy treatment for cancer, nor
  • actively take part in one of the complementary modalities offered in this pilot study.
  • participants will be required to have an ability to comfortably speak, read, and understand English.
  • participants must be fully oriented and possess the capacity to understand and provide informed consent for participation in the study.

排除标准

  • failure to meet any one of the inclusion criteria

结局指标

主要结局

FACT GOG-ntx scale

时间窗: change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks

This scale measures two outcomes:symptoms of neurotoxicity and quality of life. The FACT GOG-ntx combines the 27-item general Functional Assessment of Cancer Therapy scale (FACT-G) with an 11-item neurotoxicity subscale. Completion of the FACT-G does not require assistance and can be completed in less than five minutes. Cronbach's coefficient for each item on this scale has been demonstrated at 0.70 or higher, and the instrument is sensitive to respondent changes over time.

次要结局

  • The Brief Symptom Inventory - 18 (BSI-18)(change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks)
  • Mindful Attention Awareness scale (MAAS)(change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Clark, PhD

Assistant Professor

George Mason University

研究点 (2)

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