Clinical trial NCT05240937: The Effect of Self-compassion on Breast Cancer
Official title: The Effect of Mindfulness-Based Self-Compassion Program on Ontological Well-Being Levels of Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Self Compassion
Keywords: Mindfulness
Self Compassion
ontological well-being
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most women don't want to hear the word cancer, so they feel anxious and stressed. However, "cancer" can be the beginning of learning how to fight and being hopeful. Ontological well-being is a concept that includes the life project of the individual and the meaning of life. the life of the individual; It is a project that includes the past tense, present tense and future tense components. Mindfulness-based practices are an application that examines the psychological and physiological aspects of stress and includes the concept of self-compassion. Self-compassion requires a balanced approach to one's negative emotions. When studies with breast cancer patients are examined, it is emphasized that self-compassion has an effect on concepts such as quality of life, anxiety, depression, and body image. This research was planned to determine the effectiveness of the awareness-based self-compassion program applied to patients with breast cancer on the ontological well-being of individuals.

Detailed description: Research Design Research; In order to determine the effect of the mindfulness-based self-compassion program to be applied to patients with breast cancer on the oncological well-being of individuals, it was planned as a randomized controlled study with a pretest-posttest control group.

Research Hypotheses H1: The scores of breast cancer patients participating in the mindfulness-based self-compassion program will increase in the ontological well-being scale.

Place and Time of Research The research will be carried out at Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital between February 2022 and September 2022.

Population and Sample of the Research The population of the research will consist of individuals who were diagnosed with breast cancer, completed their treatment and are in the follow-up phase in Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital.

The sample of the study will consist of at least 70 individuals determined by power analysis.

Randomization: A pre-test will be done by pre-interviewing the patients, and patients with a maximum score of 25 on the Beck Depression Scale and patients who meet the inclusion criteria will be included in the study. Computer-assisted randomization will be performed by an independent statistician according to the list of patients who meet the inclusion criteria.

In this study, the scales will be applied as Pre-Post-Test. It does not pose any problem that will endanger the physical and mental health of the participants.

* Individual Characteristics Form
* Ontological Well-Being Scale (OWBS)
* Beck Depression Scale (BDI)

An 8-week Awareness-Based Self-Compassion Program will be applied to the experimental group determined according to the randomization results. After the application, the experimental and control groups will be given a post-test and followed up 3 months later. A mindfulness-based self-compassion program will be applied to the control group after the application is made to the experimental group and after the study is completely finished.

Expected Benefit and Widespread Effect By implementing the Awareness-Based Self-Compassion Program, by affecting the ontological well-being of patients who have overcome breast cancer and are in the control phase, discovering the meaning and purpose of life, to look at life with hope, keep motivation high for the present It is aimed to increase the sense of satisfaction related to the quality of life of the individual arising from his own self.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with breast cancer
* Being in the control process that has completed the treatment process
* Having a score of 0-25 on the Beck Depression Scale
* Not having a psychiatric diagnosis and no treatment
* be between the ages of 30-55
* Being a literate writer
* Being able to use the internet and social media easily

Exclusion Criteria:

* be in treatment
* Having a score above 25 on the Beck Depression Scale
* Having a psychiatric diagnosis and history
* to be illiterate

Primary outcomes:
measure: Ontological Well Being Scale
timeFrame: 8 Months
Secondary outcomes:
measure: Beck Depression Scale
timeFrame: 8 Months
Other outcomes:
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