Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06846060

A Mindfulness-Based Self-Compassion Program

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Survivor Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 day and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cumhuriyet University Medical Faculty Hospital

Sivas, Center, 58140, Turkey (Türkiye)

Location contact

BASHEKİM BEY, DR

CONTACT

[email protected]

+903462261326

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Self-Compassion Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Spiritual Well-Being Scale (FACIT-SP-12)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

SEMRA SEYHAN ŞAHİN, R.A. (DR)

CONTACT

[email protected]

TURKEY +905442689113

Sponsors and collaborators

Lead sponsor

Nevsehir Haci Bektas Veli University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.