Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
- Conditions
- Cancer PainOncology Pain
- Interventions
- Other: Reiki
- Registration Number
- NCT06354049
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reiki therapy Reiki This is a feasibility single arm trial of Reiki for oncology participants.
- Primary Outcome Measures
Name Time Method Recruitment rate as measured by the percentage of participants enrolled 8 weeks post enrollment Calculated by total number of participants enrolled/ total number of participants eligible and 90% is considered successful for the recruitment rate.
Retention rate as measured by the number of participants retained until the final survey point 8 weeks post enrollment 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.
Attendance rate as measured by number of sessions attended per 6 sessions 8 weeks post enrollment Total number of sessions attended per 6 sessions. Attendance rate of \>/= 70% will be considered successful
Data completeness rate 8 weeks post enrollment Data completeness of \>/= 90% is considered satisfactory
Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention 8 weeks post enrollment Number of participants treated in manner consistent with intervention/total number of participants enrolled
Acceptability as measured by the patient mean of participant satisfaction survey 8 weeks post enrollment 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)
- Secondary Outcome Measures
Name Time Method Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score Baseline, 8 weeks 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.
Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale Upto 8 weeks 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.
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States