Cancer PainNCT06354049
Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
A study testing Reiki in people with Cancer Pain and Oncology Pain, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cancer Pain, Oncology Pain
- What is being tested?
- Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2024to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Cancer Pain, Oncology Pain
- Being tested
- Reiki
- Keywords
- Reiki
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki therapy | Experimental | This is a feasibility single arm trial of Reiki for oncology participants. Receives: Other: Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 8 weeks post enrollment
Data completeness rate
Data completeness of >/= 90% is considered satisfactory
Measured: 8 weeks post enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start7 Aug 2024
- Primary completion17 Jul 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santosh Rao, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354049
- Sponsor's protocol ID
- CASE3Z24
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
- ClinicalTrials.gov ID
- NCT06354049
- Acronym / sponsor ID
- CASE3Z24
- Conditions
- Cancer Pain, Oncology Pain
- Keywords
- Reiki
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reiki therapy | Experimental | Other: ReikiThis is a feasibility single arm trial of Reiki for oncology participants. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Significant cognitive impairment that has not been corrected.
- Significant visual impairment that has not been corrected.
- Unable to provide informed consent.
- Active psychosis.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiReiki, 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. | Other | Reiki therapy |
Primary outcome
Recruitment rate as measured by the percentage of participants enrolled
Time frame: 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
Time frame: 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
Time frame: 8 weeks post enrollment
Total number of sessions attended per 6 sessions. Attendance rate of >/= 70% will be considered successful
Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention
Time frame: 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
Time frame: 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)
Data completeness rate
Time frame: 8 weeks post enrollment
Data completeness of >/= 90% is considered satisfactory
2 secondary outcomes
Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score
Time frame: Baseline, 8 weeks
Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale
Time frame: Upto 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santosh Rao, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Cancer Pain and Oncology Pain, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate as measured by the percentage of participants enrolled (time frame: 8 weeks post enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.