Impact of Acupuncture and Integrative Medicine on Patients' Quality-of-life During National Emergency and Wartime in Integrative Oncology and Inpatient Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW)
研究概览
简要总结
The current ongoing war in Israel, which began in October 2023 with a risk for spreading regionally across the Middle East, has presented a significant challenge to many patients, affecting also those receiving active oncology treatment. The present study examines a unique setting of care involving a diverse population of patients, including those receiving oncology treatment, from a widely diverse social, cultural and religious, background. Patients are offered integrative medicine treatments for 3 weeks with the goal of addressing war-related physical, emotional, and other quality of life-related concerns. After signing the informed consent form, patients will be randomly allocated to one of the two study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation modalities with acupuncture (Group B). The response to the study intervention for quality of life-related concerns will be re-assessed immediately; at 24-48 hours; and after 3 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) to determine the impact of the intervention on their QoL and concerns.
详细描述
Integrative medicine is increasingly being included in supportive and palliative care, primarily in oncology settings. The current military conflict in Israel has led to a surge in cases of emotional and physical distress, overwhelming the health profession throughout the country.
Study objectives and purpose: The primary study objective is to improve patients' QoL-related concerns including those affected by the military conflict.
Study design and setting: The study is taken place within a prospective randomized controlled methodology.
Study population: Patients of either gender, hospitalized for various indications (oncology or not) or undergoing out-patient oncology treatment, age ≥ 18 years.
Allocation to study arms and groups: Participants will be randomly assigned using the "Research Randomizer" online tool (https://www.randomizer.org/) to one of the following study groups:
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 (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
- •Patients diagnosed with cancer, age ≥ 18 years who are either hospitalized or undergoing oncology treatment in an outpatient care setting; or hospitalized for any other diagnosis
- •Patients expressing quality of life related concerns affected directly or indirectly to the war and related security status.
排除标准
- •Inability to read and provide informed consent
研究组 & 干预措施
Integrative medicine single-modality
Acupressure/relaxation only
干预措施: acupressure/relaxation (Other)
Integrative medicine multi-modality
Acupressure/relaxation with acupuncture
干预措施: acupressure/relaxation with acupuncture (Other)
结局指标
主要结局
Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW)
时间窗: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
In MYCAW, patients are asked to list and then score (from 0 to 6; 6 is most severe) their 2 most severe quality of life-related concerns
Assessment of objective physiological changes during the intervention
时间窗: During the 30 minutes integrative medicine intervention
Assessment of objective physiological changes during the 30-minute integrative medicine intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout.
次要结局
- Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS)(Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.)
- Assessing patients' quality of life-related concerns using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)(Before and three weeks post-treatment.)
研究者
Eran Ben-Arye
Director, Integrative Oncology Program
Carmel Medical Center