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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783038
• Other study ID #: 20-007168
• Secondary ID: NCI-2021-13433
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Michelle Burtis
• Phone: (507) 284-1301
• Email: burtis.michelle[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autologous Stem Cell Transplant
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Assessment of T-cell receptor repertoire and T-cell clonal diversity	Analyzed using multiplex polymerase chain reaction (PCR) RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.	Baseline, approximately 5 weeks

External Links

•   Mayo Clinic Clinical Trials