Autologous Stem Cell Transplant, Multiple Myeloma
Conditions
Brief summary
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
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.
Interventions
OTHERDistance Reiki
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.
OTHERSham distance Reiki
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported quality of life | 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 | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phenotypic characterization of circulating immune cells | Baseline, approximately 5 weeks | Measured using mass cytometry by time of flight (CyTOF) to phenotypically characterize the immune cells in peripheral blood |
| Assessment of T-cell receptor repertoire and T-cell clonal diversity | Baseline, approximately 5 weeks | Analyzed using multiplex polymerase chain reaction (PCR) RNA-sequencing to define T-cell antigen receptor (TCR) repertoire. |
Countries
United States
Outcome results
None listed