Clinical trial NCT06354049: Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
Official title: Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Pain
Oncology Pain
Keywords: Reiki
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate as measured by the percentage of participants enrolled
timeFrame: 8 weeks post enrollment
measure: Retention rate as measured by the number of participants retained until the final survey point
timeFrame: 8 weeks post enrollment
measure: Attendance rate as measured by number of sessions attended per 6 sessions
timeFrame: 8 weeks post enrollment
measure: Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention
timeFrame: 8 weeks post enrollment
measure: Acceptability as measured by the patient mean of participant satisfaction survey
timeFrame: 8 weeks post enrollment
measure: Data completeness rate
timeFrame: 8 weeks post enrollment
Secondary outcomes:
measure: Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score
timeFrame: Baseline, 8 weeks
measure: Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale
timeFrame: Upto 8 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Santosh Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: