The Effect of Self-compassion on Breast Cancer (cancer)
Primary Purpose
Breast Cancer, Self Compassion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness-based self-compassion will be applied
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Mindfulness, Self Compassion, ontological well-being
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mindfulness-based self-compassion will be applied
Control Group
Arm Description
The group in which mindfulness-based self-compassion program will be implemented.
The group in which mindfulness-based self-compassion program will not be implemented
Outcomes
Primary Outcome Measures
Ontological Well Being Scale
Ontological Well-Being (OWB) is a concept introduced by Şimşek (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 Şimşek (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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05240937
Brief Title
The Effect of Self-compassion on Breast Cancer
Acronym
cancer
Official Title
The Effect of Mindfulness-Based Self-Compassion Program on Ontological Well-Being Levels of Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beykent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Self Compassion
Keywords
Mindfulness, Self Compassion, ontological well-being
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mindfulness-based self-compassion will be applied
Arm Type
Experimental
Arm Description
The group in which mindfulness-based self-compassion program will be implemented.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The group in which mindfulness-based self-compassion program will not be implemented
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based self-compassion will be applied
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ontological Well Being Scale
Description
Ontological Well-Being (OWB) is a concept introduced by Şimşek (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 Şimşek (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.
Time Frame
8 Months
Secondary Outcome Measure Information:
Title
Beck Depression Scale
Description
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.
Time Frame
8 Months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Since the incidence of breast cancer in women is very high, the study will be conducted for women.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Behice Belkıs Çalışkan, PhD
Phone
05334824555
Email
bhcblksayan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Yasemin Kutlu, Prof. Dr.
Email
ykutlu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Self-compassion on Breast Cancer
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