Clinical trial NCT06846060: A Mindfulness-Based Self-Compassion Program
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Survivor
Keywords: breast cancer
minfulness
spiritual well-being
self-compassion
Lead sponsor: Nevsehir Haci Bektas Veli University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coopersmith Self-Esteem Scale (CSES)
timeFrame: 5 week
Secondary outcomes:
measure: Spiritual Well-Being Scale (FACIT-SP-12)
timeFrame: 5 week
Other outcomes:
Locations:
city: Si̇vas
country: Turkey
facility: Cumhuriyet University Medical Faculty Hospital
state: Center
Study officials:
affiliation: Nevsehir Haci Bektas Veli University
name: SEMRA SEYHAN SAHİN, Dr.
role: PRINCIPAL_INVESTIGATOR
References: