Clinical trial NCT06524895: Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
Official title: Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Reiki
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Medical Reiki Works, Inc
First posted: 2024-07-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consented participants will be allocated in a 1:1 ratio between the Reiki and the Sham Reiki arms. Participants will be assigned to the intervention arms using a permuted block randomized design. Blocks of two (75%) and four (25%) will be used to randomize patients.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery.

Detailed description: Reiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. Practitioners lightly place their hands directly on or above the patient's body to transmit energy from the practitioner to the recipient. This process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself. Reiki is a safe treatment modality that emphasizes spirituality in healing and wellness whose origins are rooted in ancient Tibetan traditions. The prevalence of integrating complementary therapies such as Reiki into mainstream medical practices is demonstrated by the number of hospitals that make use of these therapies to help alleviate, for example, the fatigue, pain, anxiety, and diminished quality of life experienced by cancer patients and those with other illnesses. Reiki in particular, has become more widespread in cancer centers because of its potential to reduce cancer-related symptoms and enhanced wellness without posing harm to patients.

A pilot double-blind randomized-controlled design will be used to engage 32 women in a pre-operative Reiki intervention designed by Raven Keyes called Medical Reiki© with a follow-up of two months. Women diagnosed with stage I-III breast cancer undergoing mastectomy for their treatment will be recruited to study within two weeks of surgery. Patients will be recruited to receive Medical Reiki© vs Sham Reiki (attention control) before surgery, with medical and psychosocial outcomes assessment conducted at three time points: -T0 - Baseline/pre-surgery; T1 (1-month); T2 (2 months). These assessments will either be self-administered or administered via telephone by the research team. The study The study will aim to determine the feasibility of offering Medical Reiki to breast cancer patients immediately prior to breast surgery; the impact of pre-operative Medical Reiki© vs Sham Reiki on post-operative recovery at the identified timepoints based on the specified measures of Subjective QoL metrics and objective recovery metrics.

Eligibility criteria: Inclusion Criteria:

* Ages 18-99
* Breast Cancer Diagnosis Stage 0-III
* Undergoing unilateral or bilateral mastectomy (with or without reconstruction) within 2 weeks of recruitment
* English Speaking
* From within 50 miles of Bronx County, NY

Exclusion Criteria:

* Current, uncontrolled psychiatric co-morbidities
* Pregnant women

Primary outcomes:
measure: Feasibility based on Number Screened for Inclusion
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who met Inclusion Criteria
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Assented for Informed Consent
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Completed the Informed Consent Procedure
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Agreed and Refused to Participate
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Completed Baseline Assessments
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Received Intended Intervention
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Dropped out during Follow-up Visits
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who Completed all End Line Assessments
timeFrame: 2 months
measure: Feasibility - Percentage of Patients who were Unmasked during End Line Assessments
timeFrame: 2 months
measure: Feasibility - Retention Rate
timeFrame: 2 months post-operatively
measure: Provider Fidelity
timeFrame: Immediately after intervention (before surgery), up to 1 hour
measure: Patient Fidelity
timeFrame: Immediately after intervention (before surgery), up to 1 hour
measure: Change in Mood States (Quality of Life)
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
Secondary outcomes:
measure: Stressful Life Events
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Religiosity
timeFrame: Baseline
measure: Spirituality
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Pain Inventory (Quality of Life)
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Cancer Behavior (Quality of Life)
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Blood Pressure
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Heart Rate
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
measure: Respiration Rate
timeFrame: Baseline, 1 month post-operatively, 2 month post-operatively
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alyson Moadel, PhD
role: PRINCIPAL_INVESTIGATOR
References: