Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum of Integrative Oncology and Supportive-palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Assessing patients' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS)
研究概览
简要总结
Oncology patients often suffer during hospitalization from pain, emotional distress, gastrointestinal symptoms, weakness, and quality of life (QoL)-related concerns. A large body of research has shown that acupuncture and other integrative oncology (IO) modalities, when provided in conjunction with supportive care, can significantly address and alleviate QoL-related concerns. In the proposed study, we examine an innovative model of IO and palliative care, provided to patients with cancer during hospitalization. Oncology patients at the Carmel Medical Center, Haifa, Israel, will be referred by hospital to IO/palliative care, specifying the patient's QoL-related concerns. After signing the informed consent form, patients will be asked to choose between IO intervention (Group A and B) or palliative nursing counseling only (Group C). Patients choosing to undergo integrative treatment 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 QoL-related concerns will be re-assessed immediately; at 24-48 hours; and after 2 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) and Nociception Levels (NOL) to determine the impact of the intervention on their QoL and concerns. In summary, the proposed study will examine the short-term impact of an integrative/palliative intervention on patient QoL-related concerns, comparing acupressure-relaxation modalities with or without acupuncture, as well as to patients receiving palliative nursing counseling. Following discharge, treatments will be provided at one of six participating community IO services, over a 12-week period, in coordination with the oncology and palliative care teams in the community.
详细描述
Scientific background: The provision of complementary and integrative medicine therapies within supportive and palliative oncology care (herewith, Integrative Oncology, IO) is increasingly taking place in leading oncology centers across the globe. The Society for Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO) have co-published clinical practice guidelines on the effective and safe use of these modalities for patients with cancer. The proposed study will explore the provision of IO care to patients with cancer during hospitalization, with the goal of addressing emotional distress, pain, fatigue, gastro-intestinal symptoms, and other quality of life (QoL)-related concerns.
Study objectives and purpose: The primary study objective is to improve patients' QoL-related concerns while hospitalized for a variety of cancer-related indications. This, in a clinical context in which in-patient IO interventions are provided together with palliative care, with the two teams coordinating their work. Secondary objective is to identify barriers and enablers to the continuity of IO care, following hospitalization, for patients with cancer, from the in-patient hospital to the out-patient community care setting.
Methods: Study design and setting: The proposed study will take place within a prospective randomized controlled methodology, beginning with a patient-preference stage, in which patients are asked to choose whether they are interested in undergoing IO treatments or palliative nursing counseling.
Study population: Patients of either gender, diagnosed with cancer, age ≥ 18 years and hospitalized in one of the five surgical/internal departments will be eligible for study inclusion. Participating patients will be referred to the study team by a medical healthcare provider in their respective departments, providing a list of clinical indications for the referral.
Allocation to study arms and 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 100 Years（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 and hospitalized in one of the six internal medicine and surgical departments in the hospital.
排除标准
- •Inability to read and provide informed consent
结局指标
主要结局
Assessing patients' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS)
时间窗: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Assessing the effectiveness and safety of an IO intervention involving acupressure and relaxation, either with or without the addition of acupuncture, on the severity of QoL-related concerns among hospitalized oncology patients. Of the three PROMs, ESAS asks respondents to score a list of 10 QoL-related concerns on a scale from 0 (no symptom) to 10 (worst severity of the symptom).
Assessing patients' QoL-related concerns will be performed using the Measure Yourself Concerns and Wellbeing (MYCAW).
时间窗: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Of the three PROMs used to assess patients' QoL, in MYCAW, patients to list and then score (from 0 to 6; 6 is most severe) their 2 most severe QoL-related concerns.
Assessing patients' QoL-related concerns will be performed using the European Organization for Research and Treatment of Cancer Quality of Life(EORTC QLQ-C30).
时间窗: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
EORTC QLQ C-30 asks a number of QoL-related clusters of concerns, from 1 (not at all) to 4 (very much).
Assessment of objective physiological changes during the intervention
时间窗: During the 30 minutes intervention
Assessment of objective physiological changes during the 30-minute intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout. At the same time, nociceptive levels (NOL) will be monitored using a PMD-200 device (Medasense, Ramat Gan, Israel).
次要结局
- Identifying the most commonly reported QoL-related concerns of hospitalized oncology patients. This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.(Before and immediately following the 30-minute intervention.)
- Identifying barriers and enablers to the continuity of integrative oncology care.This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.(Two weeks for patients with localized cancer; 12 weeks for patients with advanced cancer)
研究者
Eran Ben-Arye
Director, Integrative Oncology Program
Carmel Medical Center