Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05057078 |
| Other study ID # |
OnerCengiz |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Ankara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
