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

2026年7月8日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

12

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Irvine、California、アメリカ、92617
        • 募集
        • UCI Health Susan Samueli Integrative Health Institute
        • コンタクト：
        • 副調査官：
          • Dalia Kagramanov, PhD
      • Orange、California、アメリカ、92868
        • 募集
        • UCI Health
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：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.

他の名前：
  • Biofield therapy
他の：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).
他の：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.

他の名前：
  • Biofield therapy

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Fatigue (Multidimensional Fatigue Symptom Inventory-Short Form Total Score)
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Psychological Distress
時間枠：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
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Recruitment Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of California, Irvine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月20日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2026年4月10日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月10日

QC基準を満たした最後の更新が送信されました

2026年7月8日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY00000374

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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