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

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354049
• Other study ID #: CASE3Z24
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Case Comprehensive Cancer Center
• Contact: Santosh Rao, MD
• Phone: 858-945-2446
• Email: Santosh.Rao[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Neoplasms
• Oncology Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Data completeness rate	Data completeness of >/= 90% is considered satisfactory	8 weeks post enrollment
Secondary	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
Secondary	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