NCT06846060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

28 days

First QC Date

February 15, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

breast cancerminfulnessspiritual well-beingself-compassion

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 week

Secondary Outcomes (1)

  • Spiritual Well-Being Scale (FACIT-SP-12)

    5 week

Study Arms (2)

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.

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.

Interventions

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.

intervention group

Eligibility Criteria

Age18 Days+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen diagnosed with breast
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Being diagnosed with any mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University Medical Faculty Hospital

Sivas, Center, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • SEMRA SEYHAN SAHİN, Dr.

    Nevsehir Haci Bektas Veli University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEMRA SEYHAN ŞAHİN, R.A. (DR)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT DR

Study Record Dates

First Submitted

February 15, 2025

First Posted

February 25, 2025

Study Start

March 3, 2025

Primary Completion

March 31, 2025

Study Completion

April 7, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations