The Effect of Distance Reiki on Patient Reported Quality of Life, Correlated With Changes in Immune Repertoires Among Multiple Myeloma Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in patient-reported quality of life
研究概览
简要总结
This research study is being done to determine if Distance Reiki therapy offers a quality of life benefit, and improves immunity compared to patients receiving Sham Distance Reiki therapy or no additional Reiki intervention.
详细描述
Reiki is a popular complementary medicine modality sought after by patients. This non- intrusive Japanese based therapy centers on the guiding of energy through a Reiki practitioner to the patient which facilitates innate healing by modulation of energy fields. Reiki is formally classified as biofield therapy by the National Center for Complementary and Alternative Medicine (NCCAM).
Current research indicates that Reiki shows promise as a noninvasive healing tool for mind and body, particularly among patients with cancer. However, the data validating the effectiveness of Reiki integrated within a structured medical paradigm and the effect on cancer immunity remains unknown.
Given the clear demand for Reiki among cancer patients but skepticism within the medical community, this trial will aim to determine an objective patient reported quality of life (PRQoL) benefit by utilizing validated tools, in order to effectively implement Reiki into traditional medical practice.
Multiple myeloma patients are at high risk of serious illness from the COVID-19 virus during this pandemic, and so distance Reiki will be carried out via video conferencing platform.
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)
盲法说明
This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
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
- •Age ≥ 18 years
- •Patients with Multiple Myeloma with stable disease or currently in maintenance therapy
- •English Speaking
- •Computer and internet access with video conferencing availability
排除标准
- •Evidence of disease relapse at the post-transplant follow up visit
- •Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up
结局指标
主要结局
Change in patient-reported quality of life
时间窗: Baseline, approximately 5 weeks
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey. PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured (eg. more Fatigue, more Physical Function)
Change in patient-reported overall quality of life
时间窗: Baseline, approximately 5 weeks
Measured using the single item Linear Analogue Self-Assessment (LASA) that uses a 10-point Likert scale, where 0=as bad as it can be and 10=as good as it can be
Acceptability of Distance Reiki among multiple myeloma (MM) outpatients.
时间窗: Approximately 5 weeks
Measured by using the "Was it worth it" (WIWI) questionnaire which patients will complete upon study completion. This is a 3 item questionnaire which assesses patient satisfaction. Higher scores indicate greater acceptability of the Reiki intervention.
次要结局
- Phenotypic characterization of circulating immune cells(Baseline, approximately 5 weeks)
- Assessment of T-cell receptor repertoire and T-cell clonal diversity(Baseline, approximately 5 weeks)