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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
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.
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Immediate Reiki Intervention 		Participants randomized to this arm will receive the Reiki intervention immediately following the qualitative interview portion of the study. The intervention consists of six weekly, in-person Reiki sessions delivered by a trained practitioner, with each session lasting approximately 30 minutes in a calm, quiet setting. Participants will complete patient-reported outcome measures before and after each Reiki session to assess symptoms of fatigue, pain, and emotional distress. In addition, participants at Week 1 and Week 6 will undergo non-invasive electroencephalogram (EEG) measurements and blood sample collection to explore potential neurophysiological and biological changes. Following the intervention, participants will complete a satisfaction survey.
  • Other: Usui 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.
    Other names:
    • Biofield therapy
Other
Waitlist Control (Delayed Reiki Intervention) 		Participants randomized to this arm will first complete a six-week observation period without receiving Reiki following the qualitative interview. During this time, participants will complete regular symptom assessments. They will attend two in-person visits (Week 1 and Week 6), which will include a Sham Reiki session, and EEG measurement. Following the observation period, participants will complete a four-week washout period and then cross over to receive the Reiki intervention, consisting of six weekly, 30-minute sessions delivered by a trained practitioner (as described in the Experimental arm).
  • Other: Usui 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.
    Other names:
    • Biofield therapy

Recruiting Locations

UCI Health Susan Samueli Integrative Health Institute
Irvine, California 92617
Contact:
Dalia Kagramanov, PhD
323-961-2728
dkagrama@hs.uci.edu

UCI Health
Orange, California 92868
Contact:
Dalia Kagramanov, PhD
3239612728
dkagrama@hs.uci.edu

More Details

Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Dalia Kagramanov, PhD
323-961-2728
dkagrama@hs.uci.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.