Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07581080
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Fatigue Related to Cancer Treatment
  • Immunotherapy
  • Pain
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usui Reiki Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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: 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).

Primary Outcome Measure

Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score) [ Time Frame: Before and after each of the 6 weekly Reiki sessions ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCI Health Susan Samueli Integrative Health InstituteIrvineCalifornia92617
Dalia Kagramanov, PhD
[email protected]
323-961-2728
Dalia Kagramanov, PhD (SUB_INVESTIGATOR)
UCI HealthOrangeCalifornia92868
Dalia Kagramanov, PhD
[email protected]
3239612728

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