Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
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|ClinicalTrials.gov Identifier: NCT04783038|
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Autologous Stem Cell Transplant||Other: Distance Reiki Other: Sham distance Reiki||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||This is a single blinded randomization to True Reiki therapy, Sham reiki Therapy or No intervention|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||January 27, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Distance Reiki
Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
Other: Distance Reiki
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 Comparator: Sham Reiki
Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.
Other: Sham 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.
No Intervention: Standard of Care
Subjects will not receive any Reiki treatment
- Change in patient-reported quality of life [ Time Frame: Baseline, approximately 5 weeks ]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 [ Time Frame: 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
- 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 more acceptability of the Reiki intervention.
- Phenotypic characterization of circulating immune cells [ Time Frame: Baseline, approximately 5 weeks ]Measured using mass CyTOF to phenotypically characterize the immune cells in peripheral blood
- Assessment of T-cell receptor repertoire and T-cell clonal diversity [ Time Frame: Baseline, approximately 5 weeks ]Analyzed using multiplex PCR RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783038
|Contact: Michelle Burtis||(507) firstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Michelle Burtis 507-284-2511|
|Principal Investigator:||Martha Lacy, MD||Mayo Clinic|