12 Participants NeededMy employer runs this trial

Biofield Therapy for Cancer

Recruiting at 1 trial location
DK
Overseen ByDalia Kagramanov, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
Must be taking: Immunotherapy, Steroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with cancer who are currently receiving immunotherapy and experiencing fatigue. Participants should be able to attend in-person sessions and complete interviews and questionnaires.

Inclusion Criteria

I have been diagnosed with cancer.
Capable of giving written informed consent
I can speak, read, and write in English or Spanish.
See 5 more

Exclusion Criteria

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
I have received Reiki treatment within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Qualitative Interview

Participants participate in a one-hour, one-on-one interview about their experiences with cancer treatment and integrative care practices such as Reiki

1 week
1 visit (in-person)

Immediate Reiki Intervention

Participants receive six weekly, in-person 30-minute Usui Reiki sessions. Before and after each session, questionnaires are completed, and at the first and final sessions, blood samples and EEG measurements are taken.

6 weeks
6 visits (in-person)

Follow-up

Participants complete questionnaires about fatigue, pain, and stress four weeks after the final Reiki session, followed by a satisfaction survey.

4 weeks
1 visit (virtual)

Waitlist Observation

Participants complete a 6-week observation period with brief weekly fatigue questionnaires and two in-person sessions with EEG measurements.

6 weeks
2 visits (in-person)

Washout Period

A 4-week period with no sessions, after which participants complete questionnaires about fatigue, pain, and psychological distress.

4 weeks

Delayed Reiki Intervention

Participants receive the same six weekly, in-person 30-minute Reiki sessions as the Immediate Group, with questionnaires, blood samples, and EEG measurements.

6 weeks
6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Usui Reiki

Trial Overview

The study tests whether Usui Reiki, a gentle hands-on relaxation technique, can help reduce fatigue, pain, and stress in adult cancer patients on immunotherapy. Participants are randomly assigned to get Reiki right away or after a waiting period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Waitlist Control (Delayed Reiki Intervention)Experimental Treatment1 Intervention
Group II: Immediate Reiki InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+