Clinical trial NCT04783038: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Autologous Stem Cell Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Change in patient-reported quality of life
timeFrame: Baseline, approximately 5 weeks
measure: Change in patient-reported overall quality of life
timeFrame: Baseline, approximately 5 weeks
measure: Acceptability of Distance Reiki among multiple myeloma (MM) outpatients.
timeFrame: Approximately 5 weeks
Secondary outcomes:
measure: Phenotypic characterization of circulating immune cells
timeFrame: Baseline, approximately 5 weeks
measure: Assessment of T-cell receptor repertoire and T-cell clonal diversity
timeFrame: Baseline, approximately 5 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Martha Lacy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Joselle M. Cook, MBBS
role: PRINCIPAL_INVESTIGATOR
References: