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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reiki therapy | Experimental | This is a feasibility single arm trial of Reiki for oncology participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reiki | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santosh Rao, MD | University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| 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 |