Cancer, Fatigue Related to Cancer Treatment, Immunotherapy, Pain, Stress
Conditions
Keywords
Reiki, Immunotherapy, Cancer, fatigue, pain, biofield therapy
Brief summary
Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms. The purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care. The secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement. Lastly, the third aim is to explore participants' experiences with Reiki through guided interviews. Participants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups: Immediate Reiki Group: If participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience. Waitlist Group: If they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience. The investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.
Interventions
OTHERUsui Reiki Intervention
This study evaluates a standardized Usui Reiki intervention delivered by a trained Reiki Master (Level III). Participants will receive six weekly, in-person sessions, each lasting approximately 30 minutes, in a quiet clinical setting. During each session, participants rest in a reclined position with minimal sensory stimulation (e.g., optional blindfold and earplugs), while the practitioner places their hands just above the body at standardized positions. The intervention is structured to ensure consistency across participants, including fixed session frequency, duration, and a single trained practitioner. It is implemented in patients undergoing active immunotherapy and includes multimodal assessments, such as patient-reported outcomes, electroencephalogram (EEG) measurements, and blood-based biomarkers collected at specified time points to explore potential clinical and biological effects.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This study uses a randomized crossover design. Participants are assigned to one of two groups: an Immediate intervention group or a waitlist control group. The immediate group receives weekly Reiki sessions for six weeks. The waitlist group first completes a six-week observation period, during which no active Reiki is provided, followed by a four-week washout period, and then crosses over to receive the same six-week Reiki intervention. This design allows all participants to receive the intervention while enabling comparison between those receiving Reiki and those not yet receiving it. The crossover approach also allows participants to serve as their own comparison over time, supporting evaluation of changes in symptoms across different study periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be greater than 18 years of age. * Currently diagnosed with cancer. * Actively receiving immunotherapy treatment with ICI (PD1 or -PD-L1 inhibitor (single-agent immunotherapy or immunotherapy in combination with other agents; also including the use of steroids if applicable) * Report clinically significant fatigue over the past 7 days. * Able to travel to the study site to receive Reiki treatments once a week. * Understanding and willing to complete all study procedures. * Capable of giving written informed consent. * Proficient ability to speak, read, and write in English or Spanish.
Exclusion criteria
* Individuals currently receiving or received Reiki treatment in the past 30 days * Currently diagnosed with a severe psychiatric illness (i.e. schizophrenia, dementia, major depression with suicidal ideations) * Currently pregnant or intending to become pregnant during the study timeframe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score) | Before and after each of the 6 weekly Reiki sessions | Fatigue will be assessed using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), a validated self-report questionnaire measuring general, physical, emotional, and mental fatigue, as well as vigor. Scores will be used to evaluate changes in fatigue severity over time. Total scores range from -24 to 96, with higher scores indicating greater fatigue (worse outcome). |
| Change in Pain | Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session) | Pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain (higher scores = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Distress | Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session). | Psychological distress will be measured using the Rotterdam Symptom Checklist (RSCL), which assesses emotional symptoms such as anxiety and depression. Scores typically range from 0 to 100 (standardized scale), with higher scores indicating greater psychological distress (worse outcome). |
| Inter-Brain Coherence Between Patient and Practitioner | Week 1 and Week 6 of each arm | Electroencephalogram (EEG) recordings will be collected to explore changes in brain activity associated with the intervention. EEG data will be collected via Brain Products EEG system with 32-channel water-based nets, a sampling frequency of 500Hz, and electrode impedance below 50 KΩ. EEG caps from the participant and practitioner will be attached to the same EEG amplifier (BrainAmp) ensuring millisecond-precision alignment. The study will compute Power Spectral Density (PSD) in all standard EEG frequency bands as well as hyper scanning measures of inter-brain coherence. |
| Change in Inflammatory Biomarkers (Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels) | Week 1 and Week 6 of the intervention arm | Blood samples will be collected to assess potential changes in inflammatory biomarkers associated with the intervention. Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels will be quantified using commercially available multiplex and ELISA kits. |
Countries
United States
Contacts
CONTACTDalia Kagramanov, PhD
Outcome results
None listed