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

8 luglio 2026 aggiornato da: Alexandre Chan, University of California, Irvine

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • California
      • Irvine, California, Stati Uniti, 92617
        • Reclutamento
        • UCI Health Susan Samueli Integrative Health Institute
        • Contatto:
        • Sub-investigatore:
          • Dalia Kagramanov, PhD
      • Orange, California, Stati Uniti, 92868
        • Reclutamento
        • UCI Health
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.

Altri nomi:
  • Biofield therapy
Altro: 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).
Altro: 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.

Altri nomi:
  • Biofield therapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score)
Lasso di tempo: 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).
Before and after each of the 6 weekly Reiki sessions
Change in Pain
Lasso di tempo: 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)
Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Psychological Distress
Lasso di tempo: 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).
Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session).
Inter-Brain Coherence Between Patient and Practitioner
Lasso di tempo: 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.
Week 1 and Week 6 of each arm
Change in Inflammatory Biomarkers (Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels)
Lasso di tempo: 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.
Week 1 and Week 6 of the intervention arm

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rate
Lasso di tempo: Throughout recruitment period (up to approximately 16 weeks)
Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period, multiplied by 100 and reported as a percentage.
Throughout recruitment period (up to approximately 16 weeks)
Participant Beliefs, Perspectives and Experiences with Integrative Oncology Tools Via Qualitative Interview
Lasso di tempo: Pre-intervention (baseline)
Semi-structured interviews will be conducted with each participant to explore participants' experiences with Reiki and other supportive care tools, including perceived benefits, challenges, and overall acceptability.
Pre-intervention (baseline)
Retention Rate
Lasso di tempo: Throughout the study up until study completion, on average between 11-17 weeks depends on the arm participants are randomized to. For Immediate Reiki Arm (Week 11), For Waitlist Control Group (Week 17).
Retention rate will be calculated as the number of participants who complete the study divided by the number of participants enrolled, multiplied by 100 and reported as a percentage.
Throughout the study up until study completion, on average between 11-17 weeks depends on the arm participants are randomized to. For Immediate Reiki Arm (Week 11), For Waitlist Control Group (Week 17).
Adherence to Reiki Sessions
Lasso di tempo: Throughout the study intervention arm (Weeks 1 to 6)
Adherence will be calculated as the number of completed Reiki sessions divided by the number of scheduled Reiki sessions, multiplied by 100 and reported as a percentage. Adherence may also be summarized as the proportion of participants completing all 6 sessions.
Throughout the study intervention arm (Weeks 1 to 6)
Participant Satisfaction with Reiki Intervention
Lasso di tempo: For participants in the immediate Reiki arm, satisfaction is measured 4 weeks following completion of the Reiki intervention. For participants in the waitlist control group, satisfaction will be measured at the end of the Reiki intervention arm (Week 17)
Participant satisfaction will be assessed using a study satisfaction questionnaire administered after the intervention arm. This will be calculated using a 5-point Likert scale with higher scores indicating greater satisfaction.
For participants in the immediate Reiki arm, satisfaction is measured 4 weeks following completion of the Reiki intervention. For participants in the waitlist control group, satisfaction will be measured at the end of the Reiki intervention arm (Week 17)
Incidence of Treatment-Emergent Adverse Events
Lasso di tempo: Throughout study participation (up to approximately 16 weeks)
Safety will be assessed by recording the number, type, and severity of treatment-emergent adverse events occurring after the start of the intervention. Adverse events will be summarized as counts and proportions of participants experiencing at least one adverse event. Adverse events monitoring will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Throughout study participation (up to approximately 16 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, Irvine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 aprile 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

10 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00000374

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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