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

Not Applicable

Recruiting

• Conditions: Multiple Myeloma; Autologous Stem Cell Transplant
• Interventions: Other: Distance Reiki; Other: Sham distance Reiki

• Registration Number: NCT04783038
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-07
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distance Reiki	Distance Reiki	Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
Sham Reiki	Sham distance Reiki	Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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 more acceptability of the Reiki intervention.
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) assessment that uses a 10-point Likert scale, where 0=as bad as it can be and 10=as good as it can be

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States