Breast CancercancerNCT05240937
The Effect of Self-compassion on Breast Cancer
A study testing mindfulness-based self-compassion will be applied in people with Breast Cancer and Self Compassion, run by University of Beykent.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Self Compassion
- What is being tested?
- mindfulness-based self-compassion will be applied
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- be in treatment
- Having a score above 25 on the Beck Depression Scale
- Having a psychiatric diagnosis and history
- to be illiterate
Trial locations and contacts
No sites are listed yet.
Fatma Yasemin Kutlu, Prof. Dr. contact
About this study
Official title: The Effect of Mindfulness-Based Self-Compassion Program on Ontological Well-Being Levels of Breast Cancer Patients
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.
Read the 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
- Being tested
- mindfulness-based self-compassion will be applied
- Keywords
- Mindfulness, Self Compassion, ontological well-being
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based self-compassion will be appliedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based self-compassion will be applied | Experimental | The group in which mindfulness-based self-compassion program will be implemented. Receives: Behavioral: mindfulness-based self-compassion will be applied |
| Control Group | No intervention | The group in which mindfulness-based self-compassion program will not be implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Months
Secondary outcomes (1)
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.
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behice Belkıs ÇALIŞKAN, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240937
- Sponsor's protocol ID
- 2021/32
- Acronym
- cancer
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Self-Compassion Program on Ontological Well-Being Levels of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05240937
- Acronym / sponsor ID
- cancer / 2021/32
- Conditions
- Breast Cancer, Self Compassion
- Keywords
- Mindfulness, Self Compassion, ontological well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based self-compassion will be applied | Experimental | Behavioral: mindfulness-based self-compassion will be appliedThe group in which mindfulness-based self-compassion program will be implemented. |
| Control Group | No intervention | –The group in which mindfulness-based self-compassion program will not be implemented |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- be in treatment
- Having a score above 25 on the Beck Depression Scale
- Having a psychiatric diagnosis and history
- to be illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based self-compassion will be appliedA mindfulness-based self-compassion program will be applied to this group of patients who have had breast cancer and have fully completed their treatment. | Behavioural | mindfulness-based self-compassion will be applied |
Primary outcome
Ontological Well Being Scale
Time frame: 8 Months
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.
1 secondary outcome
Beck Depression Scale
Time frame: 8 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Yasemin Kutlu, Prof. Dr. contact
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based self-compassion will be applied in people with Breast Cancer and Self Compassion, run by University of Beykent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behice Belkıs Çalışkan, PhD (05334824555, bhcblksayan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ontological Well Being Scale (time frame: 8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.