- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575386
The Effect of Video-Assisted Mindfulness-Based Breathing on Quality of Life and Mental Well-Being in Individuals With Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast cancer is one of the most common malignancies worldwide and represents a significant public health burden. Individuals diagnosed with breast cancer frequently experience a wide range of physical and psychological challenges, including fatigue, pain, anxiety, depression, and decreased quality of life. These challenges may persist during and after treatment, highlighting the need for supportive and integrative care approaches.
Mindfulness-based interventions have gained increasing attention in oncology care due to their potential to improve psychological well-being and quality of life. Among these approaches, mindfulness-based breathing is a simple, non-invasive, and cost-effective method that focuses on increasing awareness of the present moment through controlled breathing. This practice may enhance parasympathetic nervous system activity and help reduce stress and anxiety.
Although mindfulness-based interventions have been studied in cancer populations, there is limited evidence specifically focusing on structured, video-assisted mindfulness-based breathing interventions in individuals with breast cancer. Therefore, this study aims to evaluate the effectiveness of a video-assisted mindfulness-based breathing program on quality of life and mental well-being in breast cancer patients.
This study is designed as a randomized controlled, single-blind clinical trial. A total of 50 participants diagnosed with breast cancer will be randomly assigned to either an intervention group (n=25) or a control group (n=25). The intervention group will receive a face-to-face training session on mindfulness-based breathing, followed by a 6-week daily practice supported by a 5-minute instructional video delivered through an online platform. Adherence to the intervention will be monitored through digital tracking systems and weekly follow-ups.
The control group will receive routine clinical care without additional intervention. Data will be collected at baseline and after the 6-week intervention period.
The primary outcomes of the study are quality of life and mental well-being. Quality of life will be assessed using the EORTC QLQ-C30 and EORTC BR23 scales, and mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
This study aims to contribute to the literature by providing evidence on a standardized, video-assisted mindfulness-based breathing intervention tailored for individuals with breast cancer. The findings are expected to support the integration of non-pharmacological, accessible, and cost-effective interventions into oncology care and nursing practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: gözde koçak
- Phone Number: +905419129438
- Email: gozde.kocakk@outlook.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
✔ Exclusion Criteria: Diagnosis of another type of cancer Presence of psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression, anxiety disorders) Stage IV breast cancer Presence of respiratory problems Previous or current experience with yoga or meditation Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
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.
|
|
No Intervention: Control Group
Participants will receive routine clinical care without any additional intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline and 6 weeks after randomization
|
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
Time Frame: Baseline and 6 weeks after randomization
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GK-MB-BREAST-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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