Breast CancerNCT07575386
The Effect of Video-Assisted Mindfulness-Based Breathing on Quality of Life and Mental Well-Being in Individuals With Breast Cancer
A study testing Mindfulness-Based Breathing in people with Breast Cancer, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-Based Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 2 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Mindfulness-Based Breathing
- Keywords
- Breast Cancer, Mindfulness, Quality of Life, Mental Well-being
- Medical subject headings
- Breast Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based BreathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Breathing |
| Control Group | No intervention | Participants will receive routine clinical care without any additional intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start2 Sep 2026 (estimated)
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving video-assisted mindfulness-based breathing or a control group receiving routine care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Koçak, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575386
- Sponsor's protocol ID
- GK-MB-BREAST-RCT-2026
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Mindfulness-Based Breathing on Quality of Life and Mental Well-Being in Individuals With Breast Cancer
- ClinicalTrials.gov ID
- NCT07575386
- Acronym / sponsor ID
- GK-MB-BREAST-RCT-2026
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Mindfulness, Quality of Life, Mental Well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving video-assisted mindfulness-based breathing or a control group receiving routine care.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mindfulness-Based BreathingParticipants 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. |
| Control Group | No intervention | –Participants will receive routine clinical care without any additional intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based BreathingA 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. | Behavioural | Experimental Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Breathing in people with Breast Cancer, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gözde koçak (+905419129438, gozde.kocakk@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline and 6 weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.