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

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ClinicalTrials.gov Identifier: NCT04783038
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Martha Q. Lacy, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Autologous Stem Cell Transplant Other: Distance Reiki Other: Sham distance Reiki Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
Primary Purpose: Supportive Care
Official Title: The Effect of Distance Reiki on Patient Reported Quality of Life, Correlated With Changes in Immune Repertoires Among Multiple Myeloma Patients: A Pilot Study
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Distance Reiki
Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
 Other: Distance 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.
Sham Comparator: Sham Reiki
Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.
 Other: Sham 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.
No Intervention: Standard of Care
Subjects will not receive any Reiki treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change in patient-reported quality of life [ Time Frame: Baseline, approximately 5 weeks ]
    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)

  2. Change in patient-reported overall quality of life [ Time Frame: Baseline, approximately 5 weeks ]
    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

  3. Acceptability of Distance Reiki among multiple myeloma (MM) outpatients. [ Time Frame: 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 more acceptability of the Reiki intervention.


Secondary Outcome Measures :
  1. Phenotypic characterization of circulating immune cells [ Time Frame: Baseline, approximately 5 weeks ]
    Measured using mass CyTOF to phenotypically characterize the immune cells in peripheral blood

  2. Assessment of T-cell receptor repertoire and T-cell clonal diversity [ Time Frame: Baseline, approximately 5 weeks ]
    Analyzed using multiplex PCR RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783038


Contacts
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Contact: Michelle Burtis (507) 284-1301 burtis.michelle@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michelle Burtis    507-284-2511      
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Martha Lacy, MD Mayo Clinic
More Information
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Responsible Party: Martha Q. Lacy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04783038    
Other Study ID Numbers: 20-007168
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases