A Mindfulness-Based Self-Compassion Program

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Survivor

• Registration Number: NCT06846060
• Lead Sponsor: Nevsehir Haci Bektas Veli University

Brief 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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-03-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• 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

Exclusion Criteria

• Being diagnosed with any mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Coopersmith Self-Esteem Scale (CSES)	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.

Secondary Outcome Measures

Name	Time	Method
Spiritual Well-Being Scale (FACIT-SP-12)	5 week	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

Trial Locations

Locations (1)

Cumhuriyet University Medical Faculty Hospital; 🇹🇷 Si̇vas, Center, Turkey