Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
Primary Purpose
Multiple Myeloma, Autologous Stem Cell Transplant
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distance Reiki
Sham distance Reiki
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma
Eligibility 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Distance Reiki
Sham Reiki
Standard of Care
Arm Description
Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.
Subjects will not receive any Reiki treatment
Outcomes
Primary Outcome Measures
Change in patient-reported quality of life
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)
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
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.
Secondary Outcome Measures
Phenotypic characterization of circulating immune cells
Measured using mass CyTOF to phenotypically characterize the immune cells in peripheral blood
Assessment of T-cell receptor repertoire and T-cell clonal diversity
Analyzed using multiplex PCR RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04783038
Brief Title
Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Autologous Stem Cell Transplant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distance Reiki
Arm Type
Active Comparator
Arm Description
Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
Arm Title
Sham Reiki
Arm Type
Sham Comparator
Arm Description
Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will not receive any Reiki treatment
Intervention Type
Other
Intervention Name(s)
Distance Reiki
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham distance Reiki
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient-reported quality of life
Description
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)
Time Frame
Baseline, approximately 5 weeks
Title
Change in patient-reported overall quality of life
Description
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
Time Frame
Baseline, approximately 5 weeks
Title
Acceptability of Distance Reiki among multiple myeloma (MM) outpatients.
Description
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.
Time Frame
Approximately 5 weeks
Secondary Outcome Measure Information:
Title
Phenotypic characterization of circulating immune cells
Description
Measured using mass CyTOF to phenotypically characterize the immune cells in peripheral blood
Time Frame
Baseline, approximately 5 weeks
Title
Assessment of T-cell receptor repertoire and T-cell clonal diversity
Description
Analyzed using multiplex PCR RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.
Time Frame
Baseline, approximately 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Burtis
Phone
(507) 284-1301
Email
burtis.michelle@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Lacy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Burtis
Phone
507-284-2511
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
We'll reach out to this number within 24 hrs