The Effect of Self-compassion on Breast Cancer

NCT ID: NCT05240937

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-11-15

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.

Conditions

Breast Cancer; Self Compassion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mindfulness-based self-compassion will be applied

The group in which mindfulness-based self-compassion program will be implemented.

Group Type: EXPERIMENTAL

mindfulness-based self-compassion will be applied

Intervention Type: BEHAVIORAL

A mindfulness-based self-compassion program will be applied to this group of patients who have had breast cancer and have fully completed their treatment.

Control Group

The group in which mindfulness-based self-compassion program will not be implemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mindfulness-based self-compassion will be applied

A mindfulness-based self-compassion program will be applied to this group of patients who have had breast cancer and have fully completed their treatment.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Beykent

OTHER

Sponsor Role: lead

Responsible Party

Behice Belkıs ÇALIŞKAN

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Behice Belkıs Çalışkan, PhD

Role: CONTACT

bhcblksayan@gmail.com

05334824555

Fatma Yasemin Kutlu, Prof. Dr.

Role: CONTACT

ykutlu@gmail.com

Other Identifiers

2021/32

Identifier Type: -

Identifier Source: org_study_id