Breast Cancer SurvivorNCT06846060
A Mindfulness-Based Self-Compassion Program
A study testing Mindfulness-Based Self-Compassion Program in people with Breast Cancer Survivor, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels. Read more about this study
- Who is it for?
- Ages 18 days and older, women only
- Conditions the study is for
- Breast Cancer Survivor
- What is being tested?
- Mindfulness-Based Self-Compassion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 7 Apr 2026
- 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 18 days and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women diagnosed with breast cancer,
- Women who are aware that they have been diagnosed with breast cancer,
- Women who volunteer to participate in the study,
- Women over the age of 18 with sufficient communication skills
Who cannot join
- Being diagnosed with any mental illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cumhuriyet University Medical Faculty Hospital
Sivas, Center, 58140
About this study
Official title: The Effect of a Mindfulness-Based Self-Compassion Program Applied to Women Diagnosed With Breast Cancer on Spiritual Well-Being and Self-Compassion Levels: A Randomized-Controlled Study
The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels.
Read the detailed description
The research was designed experimentally. The research will be conducted between February 2025 and April 2025 with female patients diagnosed with breast cancer who were treated in the oncology service of Cumhuriyet University Faculty of Medicine hospital in Sivas-Central province in the middle of Turkey and who meet the inclusion criteria. The study will be carried out face to face after obtaining the necessary institutional permissions. Participants to be included in the research will be included in the sample by taking into account the inclusion criteria at each stage. After the subject, purpose and method of the study are explained to the participants to be included in the study, they will be asked to fill out the informed consent form. Participants will then be divided into intervention and control groups by simple randomization method. Before the intervention, an information form, Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to both groups. The implementation of the study will be carried out at the patient's convenience, in a time period that will not interfere with his treatment in any way, and in a special area determined by the hospital management, while preserving his privacy. A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group. No intervention will be applied to the control group. At the end of the intervention program, the Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be administered to both groups.
- Conditions
- Breast Cancer Survivor
- Being tested
- Mindfulness-Based Self-Compassion Program
- Keywords
- breast cancer, minfulness, spiritual well-being, self-compassion
- 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 ProgramBehavioural
Mindfulness-based intervention programs are a program that includes a special session in which body and mind are integrated, and consists of homework for participants on yoga, meditation and a mindfulness-based approach to vital events in order to be aware of the moment. The conscious awareness-based self-compassion program, created in line with the literature, consists of 8 sessions in total, in groups of 5-8 people, on the same day and time every week. There are specific goals and objectives for each session, and each session also has a separate theme along with its subject.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group Awareness program intervention programs (Mindfullness) are a special comprehensive program that integrates the body and mind and consists of payments related to temporary local treatment of current yoga, diversity and awareness of the moment. According to the literature, the self-compassion program kept at home for 8-year-olds consists of 8 recordings in total, two recordings per week in groups of 8 people. He has goals and objectives specific to his personal record and yet there is a separate relationship day with the subject of his one information. Receives: Behavioral: Mindfulness-Based Self-Compassion Program |
| Control group | No intervention | No intervention will be applied to the control group. Before and after the intervention program, the Coopersmith Self-Esteem Scale (GISS) and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to the cotra group simultaneously with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coopersmith Self-Esteem Scale (CSES)
Turan and Tufan (1987) adapted the scale developed by Stanley Coopersmith (1967) into Turkish. Coopersmith (1967) found the reliability coefficient of the scale to be 0.91 for women and 0.80 for men. Additionally, the Cronbach Alpha coefficient of the scale was determined as 0.86. Each item of the scale, which consists of 25 items, is determined according to two options: "Suitable for me" and "Not suitable for me". The scoring of the scale is "4" for each correct statement and "0" for each incorrect statement; the highest score that can be obtained from the scale is 100 and the lowest score is 0. As the score obtained from the scale increases, individuals' self-esteem also increases. On the scale, a self-esteem level below 50 points is considered low, and a self-esteem level of 50 points and above is considered high. There are no reverse coded items in the scale.
Measured: 5 week
Secondary outcomes (1)
Spiritual Well-Being Scale (FACIT-SP-12)
The validity and reliability of the Spiritual Well-Being Scale (FACIT-Sp29 12), which was developed by Peterman et al. (2002) to measure the spiritual well-being of the individual in all chronic diseases, including cancer, was conducted in our country by Aktürk et al. (2017). The scale, which has 3 sub-dimensions (Meaning, Peace and Faith), allows the examination of all components of spiritual well-being. The scale is Likert type and consists of 12 items. The items in the scale have a numbering system from 0 to 4 (0-Not at all, 4-Extremely). The total score of the "Meaning" sub-dimension (Items 2,3,5,8) varies between 0 and 16 points, the total score of the "Peace" sub-dimension (Items 1,4,6,7) varies between 0 and 16 points, and the total score for the "Belief" sub-dimension (Items 9,10,11,12) varies between 0 and 16 points. The total scale score varies between 0 and 48. Higher scale values indicate greater spiritual well-being. In the study conducted by Aktürk (2017) on validity a
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start3 Mar 2025
- Primary completion31 Mar 2025
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Haci Bektas Veli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra seyhan Şahin, Nevsehir Haci Bektas Veli University
- Investigators
- SEMRA SEYHAN SAHİN, Dr., Principal investigator, Nevsehir Haci Bektas Veli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846060
- Sponsor's protocol ID
- NEVU-NRS-SS-02
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2025
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mindfulness-Based Self-Compassion Program Applied to Women Diagnosed With Breast Cancer on Spiritual Well-Being and Self-Compassion Levels: A Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT06846060
- Acronym / sponsor ID
- NEVU-NRS-SS-02
- Conditions
- Breast Cancer Survivor
- Keywords
- breast cancer, minfulness, spiritual well-being, self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nevsehir Haci Bektas Veli UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 25 Feb 2025 (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.
The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels.
Detailed description
The research was designed experimentally. The research will be conducted between February 2025 and April 2025 with female patients diagnosed with breast cancer who were treated in the oncology service of Cumhuriyet University Faculty of Medicine hospital in Sivas-Central province in the middle of Turkey and who meet the inclusion criteria. The study will be carried out face to face after obtaining the necessary institutional permissions. Participants to be included in the research will be included in the sample by taking into account the inclusion criteria at each stage. After the subject, purpose and method of the study are explained to the participants to be included in the study, they will be asked to fill out the informed consent form. Participants will then be divided into intervention and control groups by simple randomization method. Before the intervention, an information form, Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to both groups. The implementation of the study will be carried out at the patient's convenience, in a time period that will not interfere with his treatment in any way, and in a special area determined by the hospital management, while preserving his privacy. A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group. No intervention will be applied to the control group. At the end of the intervention program, the Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be administered to both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Mindfulness-Based Self-Compassion ProgramA mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group Awareness program intervention programs (Mindfullness) are a special comprehensive program that integrates the body and mind and consists of payments related to temporary local treatment of current yoga, diversity and awareness of the moment. According to the literature, the self-compassion program kept at home for 8-year-olds consists of 8 recordings in total, two recordings per week in groups of 8 people. He has goals and objectives specific to his personal record and yet there is a separate relationship day with the subject of his one information. |
| Control group | No intervention | –No intervention will be applied to the control group. Before and after the intervention program, the Coopersmith Self-Esteem Scale (GISS) and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to the cotra group simultaneously with the experimental group. |
Who may qualify
- Ages
- 18 days and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women diagnosed with breast cancer,
- Women who are aware that they have been diagnosed with breast cancer,
- Women who volunteer to participate in the study,
- Women over the age of 18 with sufficient communication skills
Key exclusion criteria (1 listed)
- Being diagnosed with any mental illness
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 ProgramMindfulness-based intervention programs are a program that includes a special session in which body and mind are integrated, and consists of homework for participants on yoga, meditation and a mindfulness-based approach to vital events in order to be aware of the moment. The conscious awareness-based self-compassion program, created in line with the literature, consists of 8 sessions in total, in groups of 5-8 people, on the same day and time every week. There are specific goals and objectives for each session, and each session also has a separate theme along with its subject. | Behavioural | intervention group |
Primary outcome
Coopersmith Self-Esteem Scale (CSES)
Time frame: 5 week
Turan and Tufan (1987) adapted the scale developed by Stanley Coopersmith (1967) into Turkish. Coopersmith (1967) found the reliability coefficient of the scale to be 0.91 for women and 0.80 for men. Additionally, the Cronbach Alpha coefficient of the scale was determined as 0.86. Each item of the scale, which consists of 25 items, is determined according to two options: "Suitable for me" and "Not suitable for me". The scoring of the scale is "4" for each correct statement and "0" for each incorrect statement; the highest score that can be obtained from the scale is 100 and the lowest score is 0. As the score obtained from the scale increases, individuals' self-esteem also increases. On the scale, a self-esteem level below 50 points is considered low, and a self-esteem level of 50 points and above is considered high. There are no reverse coded items in the scale.
1 secondary outcome
Spiritual Well-Being Scale (FACIT-SP-12)
Time frame: 5 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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.
SEMRA SEYHAN SAHİN, Dr. principal investigator
Nevsehir Haci Bektas Veli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Self-Compassion Program in people with Breast Cancer Survivor, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coopersmith Self-Esteem Scale (CSES) (time frame: 5 week). 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 18 Sep 2026.