Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)

The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.

Study Overview

• Status: Completed
• Conditions: Cancer Pain; Oncology Pain
• Intervention / Treatment: Other: Reiki

Detailed Description

Reiki is a biofield therapy originating in Japan, in which a trained practitioner places their hands on or above the body of a receiver or themselves to generate a relaxation and healing response. Systematic reviews and meta-analyses report Reiki to be effective for improving psychological and physical health symptoms. With respect to adults with cancer, Reiki has been shown to improve participants' relaxation, pain, fatigue, sleep, anxiety, stress, and wellbeing/quality of life compared to care as usual. However, one study showed no improvement in comfort and wellbeing in those receiving Reiki compared to sham Reiki control, but those receiving Reiki reported improvements above usual care.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 - 89.
• Neoplasm diagnosis (i.e., ICD-10 C00 - D49) confirmed in electronic health record (EHR)/Caisis
• Receiving care at a UH Connor Whole Health Integrative Oncology Clinic.
• Reporting at least three ESAS symptoms ≥4/10 at baseline screening including fatigue and ≥2 other symptoms on the 9-item questionnaire.
• Able to speak and understand English.
• Has an email address, and access to a computer with internet and/or a mobile device with a functioning data plan

Exclusion Criteria:

• Significant cognitive impairment that has not been corrected.
• Significant visual impairment that has not been corrected.
• Unable to provide informed consent.
• Active psychosis.
• Pregnancy.
• Metastatic disease.
• Reiki therapy within 3 months of study enrollment
• Active immunotherapy, chemotherapy, or radiation treatment, or completed within 3 months before study start. Aromatase inhibitors and tamoxifen are exceptions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reiki therapy; This is a feasibility single arm trial of Reiki for oncology participants.	Other: Reiki; Reiki, originating in Japan, is a biofield therapy where a skilled practitioner places their hands on or above the body of the recipient or themselves to induce relaxation and promote healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate as measured by the percentage of participants enrolled	Calculated by total number of participants enrolled/ total number of participants eligible and 90% is considered successful for the recruitment rate.	8 weeks post enrollment
Retention rate as measured by the number of participants retained until the final survey point	Calculated by number of participants retained until the final survey time point / number of participants enrolled. 70% of participant retention until the final survey time point will be considered successful.	8 weeks post enrollment
Attendance rate as measured by number of sessions attended per 6 sessions	Total number of sessions attended per 6 sessions. Attendance rate of >/= 70% will be considered successful	8 weeks post enrollment
Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention	Number of participants treated in manner consistent with intervention/total number of participants enrolled	8 weeks post enrollment
Acceptability as measured by the patient mean of participant satisfaction survey	As assessed by participants mean for the Participants' satisfaction survey with the Reiki sessions, measured on a scale from 0 (Not at all satisfied) to 10 (Completely satisfied)	8 weeks post enrollment
Data completeness rate	Data completeness of >/= 90% is considered satisfactory	8 weeks post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score	Changes from baseline in Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Activities, Pain Interference all measured by T-score, a 11 point numerical rating scale, with higher scores representing more pain calculated from a 5 point Likert scale, with higher scores representing more of the concept being measured.	Baseline, 8 weeks
Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale	The rate of intensity of common cancer symptoms, including pain, nausea, anxiety, fatigue, and well-being as measured using ESAS scale of 0 to 10 where, 0 is no pain to 10 as worst possible pain.	Upto 8 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Santosh Rao, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): August 7, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Reiki
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Therapeutic Touch
• Other Study ID Numbers: CASE3Z24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When sharing IPD via open access, the lack of restrictions leads to greater risk of re-identifying individuals. Data could be inappropriately merged with other data to facilitate re-identification.The small study population makes this more likely. On the other hand, sharing IPD via controlled access is burdensome. It requires resources that the investigator does not have (setting up the infrastructure and policies, administering and reviewing data requests, preparing data and distributing data). The personnel time for such an endeavor was not budgeted nor does the investigator have the financial resources to include it in the study budget

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No