NCT04783038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

January 28, 2021

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Phenotypic characterization of circulating immune cells

    Baseline, approximately 5 weeks

  • Assessment of T-cell receptor repertoire and T-cell clonal diversity

    Baseline, approximately 5 weeks

Study Arms (3)

Distance Reiki

ACTIVE COMPARATOR

Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.

Other: Distance Reiki

Sham Reiki

SHAM COMPARATOR

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

Other: Sham distance Reiki

Standard of Care

NO INTERVENTION

Subjects will not receive any Reiki treatment

Interventions

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.

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.

Sham Reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of disease relapse at the post-transplant follow up visit
  • Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Martha Lacy, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Joselle M. Cook, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

March 4, 2021

Study Start

January 27, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations