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

Обзор

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.

Вмешательства

• Другое 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 ensur

Первичные конечные точки

• Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score) [Срок оценки: Before and after each of the 6 weekly Reiki sessions]
• Change in Pain [Срок оценки: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session)]

Вторичные конечные точки (3)

• Change in Psychological Distress [Срок оценки: Baseline (Week 1) to Week 6 of the intervention arm (before and after each Reiki session).]
• Inter-Brain Coherence Between Patient and Practitioner [Срок оценки: 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) [Срок оценки: Week 1 and Week 6 of the intervention arm]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• UCI Health Susan Samueli Integrative Health Institute — Irvine
• UCI Health — Orange

Публикации

• 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. PMID 17627194
• 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. PMID 12652885
• 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. PMID 24582620
• 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. PMID 17351024
• 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. PMID 21998438
• 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. PMID 31046557
• 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. PMID 19922247
• 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. PMID 28874060

Идентификаторы

NCT: NCT07581080 · STUDY00000374

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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