Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Dalia Kagramanov, PhD
- Telefonnummer: 323-961-2728
- E-Mail: dkagrama@hs.uci.edu
Studienorte
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California
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Irvine, California, Vereinigte Staaten, 92617
- Rekrutierung
- UCI Health Susan Samueli Integrative Health Institute
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Kontakt:
- Dalia Kagramanov, PhD
- Telefonnummer: 323-961-2728
- E-Mail: dkagrama@hs.uci.edu
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Unterermittler:
- Dalia Kagramanov, PhD
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Orange, California, Vereinigte Staaten, 92868
- Rekrutierung
- UCI Health
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Kontakt:
- Dalia Kagramanov, PhD
- Telefonnummer: 3239612728
- E-Mail: dkagrama@hs.uci.edu
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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.
Andere Namen:
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Sonstiges: 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).
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score)
Zeitfenster: Before and after each of the 6 weekly Reiki sessions
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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).
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Before and after each of the 6 weekly Reiki sessions
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Change in Pain
Zeitfenster: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session)
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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)
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Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Psychological Distress
Zeitfenster: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session).
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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).
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Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session).
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Inter-Brain Coherence Between Patient and Practitioner
Zeitfenster: Week 1 and Week 6 of each arm
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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.
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Week 1 and Week 6 of each arm
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Change in Inflammatory Biomarkers (Cytokine (IL-1β, IL-6, TNF-alpha) and brain-derived neurotrophic factor (BDNF) levels)
Zeitfenster: Week 1 and Week 6 of the intervention arm
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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.
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Week 1 and Week 6 of the intervention arm
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Recruitment Rate
Zeitfenster: Throughout recruitment period (up to approximately 16 weeks)
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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.
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Throughout recruitment period (up to approximately 16 weeks)
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Participant Beliefs, Perspectives and Experiences with Integrative Oncology Tools Via Qualitative Interview
Zeitfenster: Pre-intervention (baseline)
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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.
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Pre-intervention (baseline)
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Retention Rate
Zeitfenster: 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).
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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.
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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).
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Adherence to Reiki Sessions
Zeitfenster: Throughout the study intervention arm (Weeks 1 to 6)
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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.
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Throughout the study intervention arm (Weeks 1 to 6)
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Participant Satisfaction with Reiki Intervention
Zeitfenster: 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)
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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.
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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)
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Incidence of Treatment-Emergent Adverse Events
Zeitfenster: Throughout study participation (up to approximately 16 weeks)
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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.
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Throughout study participation (up to approximately 16 weeks)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018 Jan 11;378(2):158-168. doi: 10.1056/NEJMra1703481. No abstract available.
- Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28.
- McManus DE. Reiki Is Better Than Placebo and Has Broad Potential as a Complementary Health Therapy. J Evid Based Complementary Altern Med. 2017 Oct;22(4):1051-1057. doi: 10.1177/2156587217728644. Epub 2017 Sep 5.
- Miles P, True G. Reiki--review of a biofield therapy history, theory, practice, and research. Altern Ther Health Med. 2003 Mar-Apr;9(2):62-72.
- Vitale A. An integrative review of Reiki touch therapy research. Holist Nurs Pract. 2007 Jul-Aug;21(4):167-79; quiz 180-1. doi: 10.1097/01.HNP.0000280927.83506.f6.
- Birocco N, Guillame C, Storto S, Ritorto G, Catino C, Gir N, Balestra L, Tealdi G, Orecchia C, Vito GD, Giaretto L, Donadio M, Bertetto O, Schena M, Ciuffreda L. The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Am J Hosp Palliat Care. 2012 Jun;29(4):290-4. doi: 10.1177/1049909111420859. Epub 2011 Oct 13.
- Gonella S, Garrino L, Dimonte V. Biofield therapies and cancer-related symptoms: a review. Clin J Oncol Nurs. 2014 Oct;18(5):568-76. doi: 10.1188/14.CJON.568-576.
- vanderVaart S, Gijsen VM, de Wildt SN, Koren G. A systematic review of the therapeutic effects of Reiki. J Altern Complement Med. 2009 Nov;15(11):1157-69. doi: 10.1089/acm.2009.0036.
- Tsang KL, Carlson LE, Olson K. Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue. Integr Cancer Ther. 2007 Mar;6(1):25-35. doi: 10.1177/1534735406298986.
- Zucchetti G, Candela F, Bottigelli C, Campione G, Parrinello A, Piu P, Vassallo E, Fagioli F. The Power of Reiki: Feasibility and Efficacy of Reducing Pain in Children With Cancer Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2019 Sep/Oct;36(5):361-368. doi: 10.1177/1043454219845879. Epub 2019 May 3.
- Sayer M, Agrawal P, Ng DQ, Kagramanov D, Trudeau J, Othy S, Acharya MM, Chan A. Incidence and predictors of immune checkpoint inhibitor treatment-related cognitive impairment in a racial and ethnic diverse population. Support Care Cancer. 2025 Jun 2;33(6):523. doi: 10.1007/s00520-025-09560-0.
- Thompson JA. New NCCN Guidelines: Recognition and Management of Immunotherapy-Related Toxicity. J Natl Compr Canc Netw. 2018 May;16(5S):594-596. doi: 10.6004/jnccn.2018.0047.
- Bagchi S, Yuan R, Engleman EG. Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance. Annu Rev Pathol. 2021 Jan 24;16:223-249. doi: 10.1146/annurev-pathol-042020-042741. Epub 2020 Nov 16.
- Blidner AG, Choi J, Cooksley T, Dougan M, Glezerman I, Ginex P, Girotra M, Gupta D, Johnson D, Shannon VR, Suarez-Almazor M, Rapoport BL, Anderson R. Cancer immunotherapy-related adverse events: causes and challenges. Support Care Cancer. 2020 Dec;28(12):6111-6117. doi: 10.1007/s00520-020-05705-5. Epub 2020 Aug 28.
- Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available.
- Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021 Dec 20;39(36):4073-4126. doi: 10.1200/JCO.21.01440. Epub 2021 Nov 1.
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Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
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Schlüsselwörter
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Andere Studien-ID-Nummern
- STUDY00000374
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