NCT07575386

Brief Summary

This study aims to evaluate the effect of video-assisted mindfulness-based breathing on quality of life and mental well-being in individuals with breast cancer. Breast cancer patients often experience physical and psychological challenges that negatively affect their quality of life. Mindfulness-based breathing is a simple, non-invasive method that may help reduce stress and improve well-being. In this randomized controlled study, participants will be assigned to either an intervention group or a control group. The intervention group will receive a face-to-face breathing training session and will practice daily mindfulness-based breathing exercises using a 5-minute video for 6 weeks. The control group will receive routine care. Outcomes will be measured at baseline and after 6 weeks using validated scales assessing quality of life and mental well-being. This study aims to provide evidence for a simple and accessible supportive care method for individuals with breast cancer.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable breast-cancer

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

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 2, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Breast CancerMindfulnessQuality of LifeMental Well-being

Outcome Measures

Primary Outcomes (2)

  • Change in Quality of Life

    Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the breast cancer-specific module (EORTC QLQ-BR23). Scores range from 0 to 100. Higher scores on global health status and functional scales indicate better quality of life, while higher scores on symptom scales indicate greater symptom burden.

    Baseline and 6 weeks after randomization

  • Change in Mental Well-Being

    Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale includes 14 positively worded items scored on a 5-point Likert scale. Total scores range from 14 to 70, with higher scores indicating higher mental well-being.

    Baseline and 6 weeks after randomization

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants will receive video-assisted mindfulness-based breathing training, including a face-to-face session followed by daily 5-minute guided breathing exercises for 6 weeks.

Behavioral: Mindfulness-Based Breathing

Control Group

NO INTERVENTION

Participants will receive routine clinical care without any additional intervention during the study period.

Interventions

A structured mindfulness-based breathing program consisting of an initial face-to-face training session followed by a 6-week daily video-guided breathing practice delivered through an online platform.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with breast cancer Aged 18 years or older Stage I, II, or III breast cancer Completed at least 4 cycles of chemotherapy Completed chemotherapy treatment Able to understand and speak Turkish Has access to a digital device (smartphone, tablet, or computer) Willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsPsychological Well-Being

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPersonal SatisfactionBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to group allocation. Participants and intervention providers will not be blinded due to the nature of the intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group receiving video-assisted mindfulness-based breathing or a control group receiving routine care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start (Estimated)

September 2, 2026

Primary Completion (Estimated)

March 2, 2027

Study Completion (Estimated)

June 2, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share