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The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients

Primary Purpose

Breast Cancer, Symptoms and Signs, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reiki
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Reiki, breast cancer, symptom control, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women with at least 3 months of breast cancer diagnosis, at least two cycles of chemotherapy, and stage 3 and 4 metastatic breast cancer. Exclusion Criteria: Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish, Those who refuse to answer the Reiki application and data collection tools, Those who want to leave the research while the research is continuing, Those who received any supplementary application in the last 6 months will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Reiki Group

    Control Group

    Arm Description

    Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) will be administered to the Reiki group. Then, under the guidance of a researcher holding a Usui Reiki Master & Teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree Reiki practitioner. On the second and on third days, 30 minutes of short Reiki will be done remotely. After 3 days and 10 days after the patients were included in the study, the post-tests will be performed by calling the patients.

    Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) will be administered to the control group. No treatment will be applied to the patients. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

    Outcomes

    Primary Outcome Measures

    Patient Descriptive Information Form
    The form created by the researchers included 11 questions covering the sociodemographic and medical characteristics.
    Change from Edmonton Symptom Diagnosis Scale
    It was developed by Bruera et al. in 1991. Ten symptoms are questioned as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being, shortness of breath and other problems. In the Turkish validity and reliability study of the scale, 3 additional symptoms (changes in the skin and nails, sores in the mouth, numbness in the hands) were added to the other problems section in line with the literature information. The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe. Pre-chemotherapy Cronbach α value of ESAS was 0.83; Cronbach's α ESAS after chemotherapy is 0.76.
    Change from European Association for Cancer Research and Treatment BR23 Quality of Life Scale
    The scale is a quality of life scale specially prepared for breast cancer by the European Cancer Research and Treatment Organization. It can be applied to all breast cancer patients, regardless of the stage of the disease and the treatment method. Its Turkish validity and reliability were evaluated by Demirci et al. in 2011. and the Cronbach alpha value was found to be 0.90. This scale is divided into two subgroups as functional and symptom scales. Scoring is made as 1 (none)-4 (very much). Higher functional dimension scores indicate higher quality of life. A high score in the symptoms dimension indicates a low quality of life, and low scores indicate a high quality of life.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    January 5, 2023
    Sponsor
    Ankara Medipol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05684458
    Brief Title
    The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients
    Official Title
    The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Medipol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to examine the effect of Reiki on symptom control and quality of life in breast cancer patients.
    Detailed Description
    Breast cancer is the world's second most common type of cancer, the most frequently diagnosed cancer in women, and the leading cause of cancer death. Energy therapies have an essential place in complementary and alternative treatments that are commonly used in breast cancer patients. Reiki, practiced by trained practitioners, is performed by activating the body's energy centers, including blood and lymph circulation, and stimulating the nervous system, thus providing energy circulation and providing mental-physical relaxation, positively affecting health. The effect of Reiki on cancer patients has been shown in studies that it can relieve pain, reduce anxiety and depression, improve quality of life and reduce fatigue. In this study, women with stage 3 and 4 metastatic breast cancer who were diagnosed with breast cancer for at least 3 months and received at least two cycles of chemotherapy in the outpatient chemotherapy unit of the Medical Oncology outpatient clinic of a training and research hospital will be included. It is aimed to reach a total of 52 women who meet the inclusion criteria and agreed to participate in the study between February 1, 2023, and July 30, 2023. Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) preliminary tests will be applied to all women. Patients will be randomized 1:1 into groups by a single therapist according to the block randomization method. Under the guidance of a researcher holding a Usui Reiki Master & Teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree Reiki practitioner. On the second and on third days, 30 minutes of short Reiki will be done remotely. No treatment will be applied to 26 patients in the control group. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Symptoms and Signs, Quality of Life
    Keywords
    Reiki, breast cancer, symptom control, quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The patients and the investigators know which group they are assigned to. Only the outcome assessor doesn't know which patient is assigned to which group.
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reiki Group
    Arm Type
    Experimental
    Arm Description
    Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) will be administered to the Reiki group. Then, under the guidance of a researcher holding a Usui Reiki Master & Teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree Reiki practitioner. On the second and on third days, 30 minutes of short Reiki will be done remotely. After 3 days and 10 days after the patients were included in the study, the post-tests will be performed by calling the patients.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) will be administered to the control group. No treatment will be applied to the patients. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.
    Intervention Type
    Procedure
    Intervention Name(s)
    Reiki
    Intervention Description
    Reiki, a non-invasive, free and safe complementary therapy method, is practiced with a series of hand positions held on the patient's body to help balance the life force energy.
    Primary Outcome Measure Information:
    Title
    Patient Descriptive Information Form
    Description
    The form created by the researchers included 11 questions covering the sociodemographic and medical characteristics.
    Time Frame
    Baseline
    Title
    Change from Edmonton Symptom Diagnosis Scale
    Description
    It was developed by Bruera et al. in 1991. Ten symptoms are questioned as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being, shortness of breath and other problems. In the Turkish validity and reliability study of the scale, 3 additional symptoms (changes in the skin and nails, sores in the mouth, numbness in the hands) were added to the other problems section in line with the literature information. The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe. Pre-chemotherapy Cronbach α value of ESAS was 0.83; Cronbach's α ESAS after chemotherapy is 0.76.
    Time Frame
    Change from baseline Edmonton Symptom Diagnosis Scale at 3rd days and 10th days
    Title
    Change from European Association for Cancer Research and Treatment BR23 Quality of Life Scale
    Description
    The scale is a quality of life scale specially prepared for breast cancer by the European Cancer Research and Treatment Organization. It can be applied to all breast cancer patients, regardless of the stage of the disease and the treatment method. Its Turkish validity and reliability were evaluated by Demirci et al. in 2011. and the Cronbach alpha value was found to be 0.90. This scale is divided into two subgroups as functional and symptom scales. Scoring is made as 1 (none)-4 (very much). Higher functional dimension scores indicate higher quality of life. A high score in the symptoms dimension indicates a low quality of life, and low scores indicate a high quality of life.
    Time Frame
    Change from baseline European Association for Cancer Research and Treatment BR23 Quality of Life Scale at 3rd days and 10th days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Only female patients with breast cancer will be included in the study.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with at least 3 months of breast cancer diagnosis, at least two cycles of chemotherapy, and stage 3 and 4 metastatic breast cancer. Exclusion Criteria: Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish, Those who refuse to answer the Reiki application and data collection tools, Those who want to leave the research while the research is continuing, Those who received any supplementary application in the last 6 months will be excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nursemin Unal
    Phone
    +905077433629
    Email
    nurse_unal@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nilay Bektaş Akpınar
    Phone
    +905319920260
    Email
    nilay.bektasakpinar@ankaramedipol.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nursemin Unal
    Organizational Affiliation
    Ankara Medipol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28595441
    Citation
    Steinhorn DM, Din J, Johnson A. Healing, spirituality and integrative medicine. Ann Palliat Med. 2017 Jul;6(3):237-247. doi: 10.21037/apm.2017.05.01. Epub 2017 May 22.
    Results Reference
    background
    PubMed Identifier
    1714502
    Citation
    Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
    Results Reference
    background
    PubMed Identifier
    8433390
    Citation
    Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
    Results Reference
    background
    PubMed Identifier
    30319064
    Citation
    Ong'udi M, Mutai P, Weru I. Study of the use of complementary and alternative medicine by cancer patients at Kenyatta National Hospital, Nairobi, Kenya. J Oncol Pharm Pract. 2019 Jun;25(4):918-928. doi: 10.1177/1078155218805543. Epub 2018 Oct 14.
    Results Reference
    background
    PubMed Identifier
    27587296
    Citation
    Frisch N, Butcher HK, Campbell D, Weir-Hughes D. Holistic Nurses' Use of Energy-Based Caring Modalities. J Holist Nurs. 2018 Sep;36(3):210-217. doi: 10.1177/0898010116665447. Epub 2016 Sep 1.
    Results Reference
    background
    PubMed Identifier
    32778391
    Citation
    Buyukbayram Z, Citlik Saritas S. The effect of Reiki and guided imagery intervention on pain and fatigue in oncology patients: A non-randomized controlled study. Explore (NY). 2021 Jan-Feb;17(1):22-26. doi: 10.1016/j.explore.2020.07.009. Epub 2020 Jul 31.
    Results Reference
    background

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    The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients

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