The Effect of Self-compassion on Breast Cancer

Breast Cancer Clinical Trial

— cancer  

Official title:

The Effect of Mindfulness-Based Self-Compassion Program on Ontological Well-Being Levels of Breast Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05240937
• Other study ID #: 2021/32
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: April 2022
• Source: University of Beykent
• Contact: Behice Belkis Çaliskan, PhD
• Phone: 05334824555
• Email: bhcblksayan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Beykent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ontological Well Being Scale	Ontological Well-Being (OWB) is a concept introduced by Simsek (2009) as a new approach to the Subjective Well-Being (SWB) perspective that exists in the fields of history, philosophy and psychology. The Ontological Well-Being Scale (OWBS), developed by Simsek (2009) in accordance with this perspective, yielded significant results in positive and negative mental health areas, and was found to be related to the concepts of internal motivation and psychological well-being. The scale, which is grouped as "Past", "Now" and "Future", includes a total of 24 question items. The scale has four sub-dimensions: "nothingness" (meaninglessness), "activation" (activity), "regret" (regret) and "hope" (hope). The scale filled out based on my self-evaluation method was evaluated on a five-point scale; Participants are expected to mark an answer between "I don't feel at all" (1 point) and "I feel very intensely" (5 points) for each question.	8 Months
Secondary	Beck Depression Scale	The Beck Depression Scale was developed by Beck in 1961 to measure the risk of depression, the level of depressive symptoms and the change in severity in adults. The Turkish validity and reliability study was carried out by Hisli in 1989. Beck Depression Inventory is a 21-item self-assessment scale. Each item is related to a behavioral feature related to depression and is scored between 0 and 3 according to the severity of depression. The total score of the scale ranges from 0 to 63. If the score is between 0 and 9, there is no depression, 10-16 points indicate mild, 17-24 points indicate moderate, and 25 and higher points indicate severe depressive symptoms. Hisli (1989) calculated the reliability coefficient of the scale as 0.80 with the item analysis method and as 0.74 with the split-test method.	8 Months