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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
University of Beykent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Mindfulness, Self Compassion, ontological well-being

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 4, 2022
    Last Updated
    April 12, 2022
    Sponsor
    University of Beykent
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    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

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