The Effect of Mindfulness Program on Spiritual Well-BeingBreast Cancer Patients
Condition: Breast Cancer; Nursing Caries
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer ranks first among the cancers seen in women in the World. Due to breast cancer,
      patients experience spiritual distress. The aim of this study is to determine the effect of
      mindfulness-based stress reduction program applied to patients with breast cancer on
      spiritual well-being.
    

Detailed description: 
      Breast cancer ranks first among the cancers seen in women in the world and in Turkey .
      Physical and psychological symptoms may occur in breast cancer depending on the disease or
      the treatment applied. These symptoms cause patients to be perceived as a life-threatening
      disease and decrease their quality of life. This situation can create a crisis situation by
      deeply affecting the physical, psychosocial, behavioral and spiritual aspects of patients. In
      such a case, the patient can start using spiritual coping methods by turning to spirituality
      while facing a painful illness. Patients diagnosed with breast cancer have difficulty in
      finding the meaning and purpose of life, question their previous beliefs about life, and
      their concerns about spirituality, both existential and religious, increase. Spiritual
      dimensions, which are an important component of the patient's quality of life, are an
      integral part of patient care. Spirituality is used as a means of coping with cancer by
      providing inner strength, peace, comfort and integrity and can play an important role in
      healing and having a good mood . Therefore, raising the spiritual well-being of women with
      breast cancer may have a positive effect on coping with the symptoms of the disease and
      treatment, thereby improving the quality of life. Studies have shown that patients with high
      spiritual well-being have a higher quality of life. In a systematic review, it was found that
      religion/spirituality is associated with pain and physical symptoms, and spiritual
      self-evaluation contributes to psychological well-being, regardless of religion. In recent
      studies with breast cancer patients, it has been determined that mindfulness therapy has a
      positive effect on the quality of life of patients in addition to spirituality. Mindfulness
      is a way of directing attention, coming from the eastern tradition of meditation. It can be
      defined as an individual's focusing his attention on what is happening now in a
      non-judgmental and accepting way. The concept of mindfulness has been used as a therapy
      method in Western psychotherapy approaches for almost three decades. The concept of
      mindfulness basically includes focusing on the moment and accepting emotions without judgment
      . It allows the person to stay in the moment by focusing their attention. Staying in the
      moment contributes to the well-being of mood by preventing the mind from focusing on the past
      or the future and preoccupying the mind with various emotions Kabat-Zinn (2005), one of the
      practitioners of conscious mindfulness therapy, stated that mindfulness is closely related to
      the spiritual traditions of Far Eastern countries. Efforts to use Mindful Awareness to
      improve psychological processes continue. No study has been found in the literature examining
      the effect of mindfulness therapy on the spiritual well-being of patients with breast cancer.
      However, there is a need for initiatives to increase spiritual well-being , which is known to
      have a significant impact on quality of life. Therefore, the aim of this study is to
      determine the effect of mindfulness-based stress reduction program applied to patients with
      breast cancer on spiritual well-being.

      METHODS This study is a single center, pretest-posttest with control group controlled trial.
      Participants will recruite in department of radiation oncology and oncology outpatient clinic
      of a tertiary hospital in Malatya from October 15, 2021 to May 15, 2022. Permission for the
      study was obtained from the ethics committee (E-41901325-050.99-14950). Written, fully
      informed consent will obtain from all participants and all data will guaranteed to be
      confidential. Participants has the right to withdraw from the study at any time. This study
      will conduct in accordance with The Consolidated Standards of Reporting Trials (CONSORT) 2010
      guidelines.

      Participants and Sampling We used the G * Power (version 3.1.9.4) test to determine the
      sample size. In the analysis performed as a priori, we referenced the Park et al. (2020)
      article. We performed prior analyses based on t-tests (mean values: difference between two
      independent mean values (two groups)). According to this, we determined that a total of 66
      patients, including 33 patients in each of the groups with 0.05 error level, 95% power and
      0.90 effect size, should be included. Aynı çalışmada drop out oranı %7.8 bulunmuştur. Given
      the likelihood of withdrawals, we will assign 35 participants to each group, with a total of
      70 participants.

      Randomization and blinding The participants will assign randomly to the groups. The simple
      full randomization method will use for group assignments. To determine the order of
      application, the names of the study groups (mindfulness program group and control group) will
      write on a piece of paper 30 times by the researcher, and the groups will select randomly by
      drawing lots. It will not possible for the researcher collecting data to be blind.

      Data collection In data collection, the Socio-demographic Characteristics Form prepared by
      the researchers in line with the literature to determine the sociodemographic characteristics
      of the patients and the FACIT-SP (Functional Evaluation of the Treatment of Chronic
      Diseases-Spiritual Well-being) scale will be used to determine the spiritual well-being of
      the patients.

      Socio-demographic Characteristics Form: This form, which was prepared by the researchers in
      line with the literature, consists of 18 questions includes patients' age, gender, marital
      status, education, employment status, occupation, presence of social security, income level,
      number of children, time of diagnosis, time to start treatment, stage of the disease, the
      presence of support in this disease, experiences that negatively affect thepatient, and
      methods of coping with them.

      FACIT-Sp-Version 4: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being
      Scala FACIT-Sp-Version 4; It is a combined version of FACIT-G consisting of 4 sub-dimensions,
      27 items, for quality of life assessment and FACIT-Sp-12, consisting of 3 sub-dimensions and
      12 items, for spiritual assessment. The scale consists of 4 subscales, namely Physical Status
      (7 items), Social Life and Family Status (7 items), Emotional Status (6 items) and Activity
      Status (7 items) and a total of 27 items (http://www.facit .org-website). The Turkish
      validity and reliability study of the scale was carried out by Aktürk.et al. (2017).
      Cronbach's alpha values were determined to be 0.87 for the FACIT-Sp: 0.78 for the meaning
      subscale, 0.81 for the peace subscale, and 0.93 for the faith subscale.

      Implementation of the initiative Before starting the study, the Socio-demographic
      Characteristics Form and the FACIT-SP (Functional Evaluation of the Treatment of Chronic
      Diseases-Spiritual Well-being) scale will be applied to the patients included in the
      mindfulness program group and control group in order to collect the pre-test data. After the
      pre-test data are collected, groups of 10 people will be formed among the patients included
      in the mindfulness program group. A mindfulness-based stress reduction program will be done
      once a week for eight weeks and will take approximately 60-90 minutes. A plan will be made
      with the patients for the day and time of the session. During this process, no application
      will be made to the control group. Meetings will be held as an online session via Zoom Video
      Communications. Post-test data will be collected from all patients after eight sessions. Each
      of the patients participating in the eight-week mindfulness-based stress reduction program
      will be retested 2 months after the program ends.

      Statistical analysis Research data will be evaluated with the SPSS 25 (Statistical Package
      for Social Science) package program. Kolmogorov-Smirnov distribution test will be used to
      examine the normal distribution and Cronbach's alpha will be used for internal consistency.
      In the evaluation of the data, number, percentage, mean, standard deviation and parametric
      (t-test, analysis of variance) or nonparametric (Mann-Whitney U, Kruskal-Wallis tests) tests
      will be used according to the normal distribution of the data.
    

Intervention name(s): mindfulness-based stress reduction program
Intervention type(s): Behavioral
Intervention description(s): groups of 10 people will be formed among the patients included in the mindfulness program group. A mindfulness-based stress reduction program will be done once a week for eight weeks and will take approximately 60-120 minutes. A plan will be made with the patients for the day and time of the session. During this process, no application will be made to the control group. Meetings will be held as an online session via Zoom Video Communications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast cancer; Spirituality; Nursing Care; Mindfulness