Multiple MyelomaNCT04783038
Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
A study testing Distance Reiki in people with Multiple Myeloma and Autologous Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Autologous Stem Cell Transplant
- What is being tested?
- Distance Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of disease relapse at the post-transplant follow up visit
- Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma, Autologous Stem Cell Transplant
- Being tested
- Distance Reiki, Sham distance Reiki
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance ReikiOther
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 ReikiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Distance Reiki | Active comparator | Subjects will be scheduled for once a week session of distance Reiki for 4 weeks. Receives: Other: Distance Reiki |
| Sham Reiki | Sham comparator | Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks. Receives: Other: Sham distance Reiki |
| Standard of Care | No intervention | Subjects will not receive any Reiki treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: Approximately 5 weeks
Secondary outcomes (2)
Phenotypic characterization of circulating immune cells
Measured using mass cytometry by time of flight (CyTOF) to phenotypically characterize the immune cells in peripheral blood
Measured: Baseline, approximately 5 weeks
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.
Measured: Baseline, approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start27 Jan 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Lacy, MD, Principal investigator, Mayo ClinicJoselle M. Cook, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783038
- Sponsor's protocol ID
- 20-007168
- Other IDs
- NCI-2021-13433
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04783038
- Acronym / sponsor ID
- 20-007168
- Conditions
- Multiple Myeloma, Autologous Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distance Reiki | Active comparator | Other: Distance ReikiSubjects will be scheduled for once a week session of distance Reiki for 4 weeks. |
| Sham Reiki | Sham comparator | Other: Sham distance ReikiSubjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks. |
| Standard of Care | No intervention | –Subjects will not receive any Reiki treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Evidence of disease relapse at the post-transplant follow up visit
- Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distance ReikiReiki 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. | Other | Distance Reiki |
| Sham distance ReikiSession 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. | Other | Sham Reiki |
Primary outcome
Change in patient-reported quality of life
Time frame: 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
Time frame: Baseline, approximately 5 weeks
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
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 greater acceptability of the Reiki intervention.
2 secondary outcomes
Phenotypic characterization of circulating immune cells
Time frame: Baseline, approximately 5 weeks
Assessment of T-cell receptor repertoire and T-cell clonal diversity
Time frame: Baseline, approximately 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Lacy, MD principal investigator
Mayo Clinic
Joselle M. Cook, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distance Reiki in people with Multiple Myeloma and Autologous Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported quality of life (time frame: Baseline, approximately 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.