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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13433 | Registry Identifier | CTRP (Clinical Trials Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distance Reiki | Active Comparator | Subjects will be scheduled for once a week session of distance Reiki for 4 weeks. |
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| Sham Reiki | Sham Comparator | Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks. |
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| Standard of Care | No Intervention | Subjects will not receive any Reiki treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distance Reiki | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported quality of life | 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) | Baseline, approximately 5 weeks |
| Change in patient-reported overall quality of life | 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 | 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 greater acceptability of the Reiki intervention. | Approximately 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phenotypic characterization of circulating immune cells | Measured using mass cytometry by time of flight (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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Lacy, MD | Mayo Clinic | Principal Investigator |
| Joselle M. Cook, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
| Sham distance Reiki | Other | 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. |
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Analyzed using multiplex polymerase chain reaction (PCR) RNA-sequencing to define T-cell antigen receptor (TCR) repertoire. |
| Baseline, approximately 5 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |