Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 4
- 主要终点
- Change in worst pain intensity assessed by the NRS
研究概览
简要总结
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.
详细描述
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:
- Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
- Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
- Examine stakeholder perspectives on non-pharmacologic approaches to pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
- •Speak Cantonese, English, or Spanish
- •Have an anticipated stay of ≥ 48 hours
- •Be aged 21 or older
- •Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled
排除标准
- •Acupuncture contraindication
- •Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
- •Admission to the psychiatric ward (e.g., for severe depression)
- •Inability to consent (e.g., cognitive impairment)
- •Prior involvement with the study (e.g., readmissions)
- •Platelets < 50,000 microliters
- •Absolute neutrophil count < 500 microliters
- •C. difficile infection
结局指标
主要结局
Change in worst pain intensity assessed by the NRS
时间窗: 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
次要结局
- Use of opioids during hospital stay(Hospital stay (average length of stay = 5 days))
- Presence and severity of common side effects(Daily for up to four hospital days)
- Cancer-related distress(Daily for up to four hospital days)
- Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)(Daily for up to four hospital days)