Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Distance Reiki on Patient Reported Quality of Life, Correlated With Changes in Immune Repertoires Among Multiple Myeloma Patients: A Pilot Study

Conditions
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Multiple Myeloma, Autologous Stem Cell Transplant

Intervention / Treatment
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* Other: Distance Reiki
* Other: Sham distance Reiki


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients with Multiple Myeloma within 6 months of their Autologous Stem Cell Transplant English Speaking Computer and internet access with video conferencing availability Exclusion Criteria: Evidence of disease relapse at the post-transplant follow up visit Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Distance Reiki<br>Subjects will be scheduled for once a week session of distance Reiki for 4 weeks. | Other: Distance Reiki<br>* Reiki therapy session performed remotely over a Zoom® video conferencing platform led by Reiki Practitioners who are also Health Care Providers at the Mayo Clinic, and have at least 6 months of experience in Reiki.<br>|
| Sham Comparator: Sham Reiki<br>Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks. | Other: Sham distance Reiki<br>* Session performed remotely over a Zoom® video conferencing platform led by a Health Care Provider employed at the Mayo Clinic, but will have no experience in Reiki and will not be a certified Reiki Practitioner.<br>|
| No Intervention: Standard of Care<br>Subjects will not receive any Reiki treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported quality of life | Measured using the PROMIS-29® (Patient-Reported Outcomes Measurement Information System) 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) | Baseline, approximately 5 weeks | 
| Change in patient-reported overall quality of life | Measured using the single item Linear Analogue Self-Assessment (LASA) assessment that uses a 10-point Likert scale, where 0=as bad as it can be and 10=as good as it can be | Baseline, approximately 5 weeks | 
| Acceptability of Distance Reiki among multiple myeloma (MM) outpatients. | 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 more acceptability of the Reiki intervention. | Approximately 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypic characterization of circulating immune cells | Measured using mass CyTOF to phenotypically characterize the immune cells in peripheral blood | Baseline, approximately 5 weeks | 
| Assessment of T-cell receptor repertoire and T-cell clonal diversity | Analyzed using multiplex PCR RNA-sequencing to define T-cell antigen receptor (TCR) repertoire. | Baseline, approximately 5 weeks |