Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06354049
Other study ID # CASE3Z24
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 30, 2024
Est. completion date March 31, 2025

Study information

Verified date May 2024
Source Case Comprehensive Cancer Center
Contact Santosh Rao, MD
Phone 858-945-2446
Email Santosh.Rao@UHhospitals.org
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03375515 - PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain Phase 3
Recruiting NCT03431922 - Endovascular Denervation in Patients With Cancer Pain N/A
Not yet recruiting NCT05265052 - 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain Phase 2
Withdrawn NCT05325164 - Methadone for 'Adenocarcinopathic' Pain Treatment Phase 3
Completed NCT02664987 - Analgesic Treatment for Cancer Pain in South East Asia N/A
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Active, not recruiting NCT04095234 - Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT) Phase 2
Recruiting NCT05800834 - Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT02609828 - Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy Phase 3
Completed NCT03331055 - PENS or TENS for Pain in Pancreatic Cancer N/A
Recruiting NCT05506878 - Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement N/A
Completed NCT00766831 - An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain Phase 4
Recruiting NCT05051735 - PARASTOP - Paracetamol With Strong Opioids Phase 3
Not yet recruiting NCT05348174 - Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients. N/A
Completed NCT05209906 - An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Completed NCT03031938 - Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies Phase 3
Not yet recruiting NCT05594459 - Early Treatment With Invasive Technique in Cancer Pain Management N/A
Withdrawn NCT04666623 - Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain Phase 2
Not yet recruiting NCT05049811 - Effects of Mobile Medicine on Cancer Patients N/A