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Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)

2021年10月21日 更新者：University of California, San Francisco

Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients

Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. Patients want to know "How can I get the most pain relief with the fewest side effects?" This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.

Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).

The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:

  1. Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
  2. Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
  3. Examine stakeholder perspectives on non-pharmacologic approaches to pain management.

研究类型

介入性

注册 (实际的)

448

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • San Francisco、California、美国、94143
        • University of California, San Francisco
      • San Francisco、California、美国、94110
        • Zuckerberg San Francisco General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
  2. Speak Cantonese, English, or Spanish
  3. Have an anticipated stay of ≥ 48 hours
  4. Be aged 21 or older
  5. Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled

Exclusion Criteria:

  1. Acupuncture contraindication
  2. Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
  3. Admission to the psychiatric ward (e.g., for severe depression)
  4. Inability to consent (e.g., cognitive impairment)
  5. Prior involvement with the study (e.g., readmissions)
  6. Platelets < 50,000 microliters
  7. Absolute neutrophil count < 500 microliters
  8. C. difficile infection

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：Treatment As Usual
Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
有源比较器：Acupuncture
Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.
程序：Acupuncture
A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
有源比较器：Pain Counseling
Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.
行为的：Pain Counseling
Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
有源比较器：Acupuncture and Pain Counseling
Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.
程序：Acupuncture
A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
行为的：Pain Counseling
Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in worst pain intensity assessed by the NRS
大体时间：Daily for up to four hospital days
Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable
Daily for up to four hospital days

次要结果测量

结果测量
措施说明
大体时间
Use of opioids during hospital stay
大体时间：Hospital stay (average length of stay = 5 days)
Total and average daily use of opioids based on morphine milligram equivalence
Hospital stay (average length of stay = 5 days)
Presence and severity of common side effects
大体时间：Daily for up to four hospital days
Nausea, vomiting, agitation, and sedation
Daily for up to four hospital days
Cancer-related distress
大体时间：Daily for up to four hospital days
Single item measure developed by the National Comprehensive Cancer Network. Participants are asked to indicate the number that best describes how much distress they are experiencing in the past week including today, 0=no distress and 10=extreme distress.
Daily for up to four hospital days
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
大体时间：Daily for up to four hospital days
The EuroQol EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EuroQol visual analogue scale (EQ VAS) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. Detailed scoring instructions are available: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
Daily for up to four hospital days

其他结果措施

结果测量
措施说明
大体时间
Pain Treatment Satisfaction Scale
大体时间：Assessed once at the end of hospital stay (average length of stay = 5 days)
The Pain Treatment Satisfaction Scale includes subscales of satisfaction with information, medical care, effectiveness, and side effects with reliability ranging from 0.83 to 0.92. Each of the subscales are scored from 0 to 100 with higher scores indicating greater satisfaction.
Assessed once at the end of hospital stay (average length of stay = 5 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, San Francisco

合作者

Patient-Centered Outcomes Research Institute

调查人员

  • 首席研究员：Maria T Chao, DrPH, MPA、University of California, San Francisco

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年1月17日

初级完成 (实际的)

2021年9月30日

研究完成 (实际的)

2021年9月30日

研究注册日期

首次提交

2018年8月30日

首先提交符合 QC 标准的

2019年4月3日

首次发布 (实际的)

2019年4月5日

研究记录更新

最后更新发布 (实际的)

2021年10月22日

上次提交的符合 QC 标准的更新

2021年10月21日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 17-23446
  • NCI-2018-02204 (注册表标识符：NCI Clinical Trials Reporting Program (CTRP))
  • 18801 (University of California, San Francisco)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

3
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