Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
NCT Number: NCT06524895
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: OTHER: Medical Reiki|OTHER: Sham Reiki
Sponsor: Albert Einstein College of Medicine
Collaborators: Medical Reiki Works, Inc
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-11-09
Completion Date: 2025-05
Locations: Montefiore Medical Center, Bronx, New York, 10461, United States

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.

Primary Outcome Measures: Feasibility based on Number Screened for Inclusion, The total number of patients screened for inclusion will be summarized and reported., 2 months|Feasibility - Percentage of Patients who met Inclusion Criteria, The number/percentage of patients who met inclusion criteria will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Assented for Informed Consent, The number/percentage of patients who assented for Informed Consent will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Completed the Informed Consent Procedure, The number/percentage of patients who completed the Informed Consent Procedure will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Agreed and Refused to Participate, The number/percentage of patients who agreed/refused to Participate will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Completed Baseline Assessments, The number/percentage of patients who completed baseline assessments will be summarized and reported., 2 months|Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm, The number/percentage of patients who who were Randomly Allocated as per allocation list to Treatment Arm will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Received Intended Intervention, The number/percentage of patients who received the intended intervention will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Dropped out during Follow-up Visits, The number/percentage of patients who dropped out during follow-up Visits will be summarized and reported., 2 months|Feasibility - Percentage of Patients who Completed all End Line Assessments, The number/percentage of patients who completed all end Line assessments will be summarized and reported., 2 months|Feasibility - Percentage of Patients who were Unmasked during End Line Assessments, The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported., 2 months|Feasibility - Retention Rate, Feasibility will be assessed based on retention of study patients in the study arms. For this study retention rate will be determined per study arm and will be equal to the ratio (in percentage) of the number of patients who completed all study activities at two months to the number of patients assigned to that study arm. For this study a retention rate of 80% is targeted., 2 months post-operatively|Provider Fidelity, Provider fidelity will be assessed based upon responses to a Reiki Fidelity Provider Survey administered immediately after the intervention session. The survey consists of 11 questions (including one question which contains three sub-questions). For purposes of assessing Provider Fidelity only the first three questions on the survey are scored. For these three questions, providers are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Not at all" or "Uncomfortable") to 10 (either "Completely" or "Very Comfortable") as to the conduct of the intervention, the degree of comfort they felt, and the degree of comfort providers perceived that their patients felt, during the session, for an overall possible scoring range of 0-30. Higher scores associated with and increased level of provider fidelity. Overall scores will be summarized at each time point using basic descriptive statistics., Immediately after intervention (before surgery), up to 1 hour|Patient Fidelity, Patient fidelity will be assessed based upon responses to a Reiki Fidelity Patient Survey administered immediately following the intervention session. The survey consists of 8 questions; however, for purposes of assessing Patient Fidelity only questions 1, 2, 6, and 7 on the survey are scored. For these four questions, patients are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Very Negative", "Uncomfortable", or "Not at all") to 10 (either "Very Positive", "Very Comfortable", or "Very Much") as to their experience with the intervention, their level of comfort with the intervention and their expectations as to the impact on physical and emotional recovery derived from the intervention, for an overall possible scoring range of 0-40. Higher scores associated with and increased level of patient fidelity. Overall scores will be summarized at each time point using basic descriptive statistics., Immediately after intervention (before surgery), up to 1 hour|Change in Mood States (Quality of Life), Change in mood states will be assessed using the Profile of Mood States (POMS) Inventory-Short form. POMS is an 11-item checklist of mood states which assesses psychological distress including tension, depression, and fatigue. The questionnaire consists of a list of adjectives and asks patients to provide a score best describing feelings associated with each particular adjective (mood state) over the past week based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), yielding an overall possible scoring range of 0-44. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of distress and negative mood states (including tension, depression, fatigue)., Baseline, 1 month post-operatively, 2 month post-operatively
Secondary Outcome Measures: Stressful Life Events, Stressful life events will be assessed using the List of Threatening Experiences - Questionnaire (LTE-Q). The LTE-Q is a 12-item survey used to assess acute stressful events that could influence quality of life and cortisol outcomes. Patients are provided with 12 questions and asked to provide a binary (Yes/No) response as to whether each event was experienced over the prior 12 month period. "No" responses are assigned a value of 0 and "Yes" responses are assigned a value of 1. Item scores are summed to derive a total score with an overall possible scoring range of 0-12. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increase in stressful life events and a negative impact on quality of life., Baseline, 1 month post-operatively, 2 month post-operatively|Religiosity, Religiosity will be assessed using the Duke University Religion Index (DUREL). The DUREL is 5-item survey that measures religious involvement in terms of public religious behavior (church activities), private behavior (praying), and intrinsic religiousness (involvement of religion in dealings in life). The first two statements ask patients about engagement with public and private religious meetings, respectively, and are scored on a scale of "1" (more than once/week; more than once/day, respectively) through "6" (never; rarely or never, respectively) based on frequency of engagement. The last three statements ask about religious beliefs/experiences based on a 5 point scale ranging from 1 ("Definitely true of me") to 5 ("Definitely not true"). Scores for the 5 statements are added for a possible overall range of 5-27. Overall scores will be summarized at each time point using basic descriptive statistics. Lower scores are associated with increased levels of religious involvement., Baseline|Spirituality, Spirituality will be assessed using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12). The FACIT-Sp-12 is a 12-item questionnaire which consists of statements which serve as a measure of spirituality that measures domains of meaning, peace, and faith. Patients are provided with 12 statements that people with similar illnesses have said are important and asked to provide a score indicating how true the particular statement is for them over the past 7 days, based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely") for an overall range of 0-48. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of spiritual well-being., Baseline, 1 month post-operatively, 2 month post-operatively|Pain Inventory (Quality of Life), Pain Severity and Pain Interference will be assessed using the Brief Pain Inventory Short Form (BPI-SF). BPI-SF consists of statements that assess the severity of pain and its impact on functioning in patients with chronic illnesses. The BPI-SF uses a 0-10 numeric rating scale for item rating for 2 subscales: Pain Severity (4 items) and Pain Interference (7 items). Patients provide a Pain Severity score between 0 ("No Pain") and 10 ("Pain as bad as you can imagine") and a mean of the 4 severity items on the BPI-SF is determined. Similarly, patients are asked to provide a Pain Interference score between 0 ("Does not Interfere") and 10 ("Completely interferes") and a mean of the 7 interference items is determined. The two subscales are added for an overall possible range of 0-110. Overall scale scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with increased pain severity and an adverse impact on daily life function., Baseline, 1 month post-operatively, 2 month post-operatively|Cancer Behavior (Quality of Life), Cancer behavior assessing four major constructs: maintaining independence; participating in medical care; coping and stress management; and managing affect, will be assessed using the Cancer Behavior Inventory Brief Form (CBI-B) form. The CBI-B survey consists of a 12-item scale which assesses how confident the patient is in performing specific behaviors during and after cancer treatment. Patients are asked to provide a score on a 9 point scale ranging from 1 ("Not at all Confident") to 9 ("Totally confident"), for an overall possible scoring range of 12-108. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of self-efficacy in coping with cancer., Baseline, 1 month post-operatively, 2 month post-operatively|Blood Pressure, Blood pressure (BP) will be reported based on medical chart reviews. BP is comprised of a systolic pressure (arterial pressure during contraction) reading and a diastolic pressure (arterial pressure between heartbeats) reading, both measured in millimeters of mercury (mmHg), and reported as a single reading (systolic/diastolic). Optimal BP ranges can vary based on demographics however, in adults, elevated BP is a risk factor for adverse cardiovascular and cerebrovascular events. Group mean BP readings will be reported using basic descriptive statistics., Baseline, 1 month post-operatively, 2 month post-operatively|Heart Rate, Heart rate (HR) will be reported in beats per minute (BPM) at rest based on medical chart reviews. Target (resting) heart rate ranges can vary based on demographics however, in adults, a lower (resting) heart rate is correlated with a higher degree of fitness and a lower incidence of cardiovascular events. Group mean HR will be reported using basic descriptive statistics., Baseline, 1 month post-operatively, 2 month post-operatively|Respiration Rate, Respiration rate (RR) will be reported in breaths per minute (bpm) at rest based on medical chart reviews. Normal respiration rates for an adult can vary based on demographics but are generally 12-18 breaths per minute. Elevated respiration rates can be indicative of anxiety or other underlying health conditions. Group mean RR readings will be reported using basic descriptive statistics., Baseline, 1 month post-operatively, 2 month post-operatively