Breast CancerNCT07474337
The Effect of Mindfulness-Based Breathing Exercises on Symptom Control
A study testing Mindfulness-Based Breathing Exercise in people with Breast Cancer, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aims to evaluate the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-Based Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 15 Aug 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Knowing their diagnosis
- Receiving chemotherapy for the first time due to a breast cancer diagnosis
- Having breast cancer stages I, II, or III (stage 4 patients were not included in the study as metastatic spread would increase symptoms and make communication with the patient difficult),
- Not receiving treatment for another cancer,
- Not having a physical disability that would prevent telephone interviews (hearing, speech),
- Not having any psychiatric disorder that would impair comprehension and understanding,
- Patients who have verbally and in writing consented to participate in the study will be included in the research.
Who cannot join
- Patients with communication problems • Patients with psychiatric problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gül DURAL
Elâzığ
Gül DURAL, pHD, 04242370000, gulkaya@firat.edu.tr
Gül DURAL, pHD
About this study
Official title: The Effect of Mindfulness-Based Breathing Exercises on Symptom Control and Salivary Cortisol Levels in Breast Cancer Patients Undergoing Chemotherapy
This randomized controlled experimental study aims to evaluate the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients receiving chemotherapy. The study population will consist of breast cancer patients undergoing chemotherapy treatment in the Oncology Department of Fırat University Hospital. A total of 72 patients who meet the inclusion criteria and volunteer to participate will be included in the study, with 36 patients in the experimental group and 36 in the control group. Data will be collected using the Personal Information Form and the Edmonton Symptom Assessment Scale. The findings of this study are expected to provide evidence regarding the effectiveness of mindfulness-based breathing exercises in improving symptom management and reducing stress levels in breast cancer patients receiving chemotherapy.
Read the detailed description
Cancer is a disease caused by the combined effect of various genetic and environmental factors that lead to the uncontrolled division and proliferation of cells. From the diagnosis stage, cancer affects the quality of life due to various symptoms associated with the disease and its treatment. This causes cancer patients to experience physiological and psychological stress. Today, many patients use non-pharmacological methods to manage these symptoms. As a result of the increasing interest of individuals in society in non-pharmacological methods, it has become a necessity for healthcare professionals, whose aim is to meet the health needs of the community, and nurses as members of the healthcare team, to play a role in these methods. One of the practices that nurses can offer patients for symptom management is mindfulness-based breathing exercises. In this body-mind-based practice, all attention is brought to the breath, enabling individuals to create awareness about their negative thoughts and feelings. This research is planned as a randomized controlled experimental study to evaluate the effect of mindfulness-based breathing exercises applied to breast cancer patients receiving chemotherapy on symptom management and salivary cortisol levels. The population of the study will consist of breast cancer patients receiving chemotherapy treatment in the Oncology Department of Fırat University Hospital. The sample will consist of patients who meet the research criteria and volunteer to participate in the study. A power analysis was conducted to determine the sample size, with a 0.05 error margin, a 0.95 confidence interval, an effect size of 0.5, and a population representation of 0.80, resulting in 72 patients for both the experimental and control groups. The total sample size for the study will be 36 patients in each group. The Personal Information Form and the Edmonton Symptom Assessment Scale will be used as data collection tools. The SPPS (Statistical Programme for Social Sciences) software package will be used to analyze the data obtained from the research. This study aims to determine the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients undergoing chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Mindfulness-Based Breathing Exercise
- Keywords
- Mindfulness-Based Breathing, Symptom Management, Salivary Cortisol, Non-Pharmacological Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Breathing ExerciseBehavioural
Mindfulness-based breathing exercises focusing attention on breathing to promote awareness and support symptom management in breast cancer patients receiving chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Breast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care. Receives: Behavioral: Mindfulness-Based Breathing Exercise |
| Control Group | No intervention | Breast cancer patients receiving chemotherapy who will receive routine care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity
Evaluation of symptom severity in breast cancer patients receiving chemotherapy using the Edmonton Symptom Assessment Scale (ESAS).
Measured: Baseline and after the intervention period (e.g., 8 weeks)
Secondary outcomes (1)
Salivary Cortisol Level
Assessment of stress level by measuring salivary cortisol levels in breast cancer patients undergoing chemotherapy.
Measured: Baseline and after the intervention period (e.g., 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Mar 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Aug 2026 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gui Dural, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474337
- Sponsor's protocol ID
- 2024/15-52
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Breathing Exercises on Symptom Control and Salivary Cortisol Levels in Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07474337
- Acronym / sponsor ID
- 2024/15-52
- Conditions
- Breast Cancer
- Keywords
- Mindfulness-Based Breathing, Symptom Management, Salivary Cortisol, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 16 Mar 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 randomized controlled experimental study aims to evaluate the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients receiving chemotherapy. The study population will consist of breast cancer patients undergoing chemotherapy treatment in the Oncology Department of Fırat University Hospital. A total of 72 patients who meet the inclusion criteria and volunteer to participate will be included in the study, with 36 patients in the experimental group and 36 in the control group. Data will be collected using the Personal Information Form and the Edmonton Symptom Assessment Scale. The findings of this study are expected to provide evidence regarding the effectiveness of mindfulness-based breathing exercises in improving symptom management and reducing stress levels in breast cancer patients receiving chemotherapy.
Detailed description
Cancer is a disease caused by the combined effect of various genetic and environmental factors that lead to the uncontrolled division and proliferation of cells. From the diagnosis stage, cancer affects the quality of life due to various symptoms associated with the disease and its treatment. This causes cancer patients to experience physiological and psychological stress. Today, many patients use non-pharmacological methods to manage these symptoms. As a result of the increasing interest of individuals in society in non-pharmacological methods, it has become a necessity for healthcare professionals, whose aim is to meet the health needs of the community, and nurses as members of the healthcare team, to play a role in these methods. One of the practices that nurses can offer patients for symptom management is mindfulness-based breathing exercises. In this body-mind-based practice, all attention is brought to the breath, enabling individuals to create awareness about their negative thoughts and feelings. This research is planned as a randomized controlled experimental study to evaluate the effect of mindfulness-based breathing exercises applied to breast cancer patients receiving chemotherapy on symptom management and salivary cortisol levels. The population of the study will consist of breast cancer patients receiving chemotherapy treatment in the Oncology Department of Fırat University Hospital. The sample will consist of patients who meet the research criteria and volunteer to participate in the study. A power analysis was conducted to determine the sample size, with a 0.05 error margin, a 0.95 confidence interval, an effect size of 0.5, and a population representation of 0.80, resulting in 72 patients for both the experimental and control groups. The total sample size for the study will be 36 patients in each group. The Personal Information Form and the Edmonton Symptom Assessment Scale will be used as data collection tools. The SPPS (Statistical Programme for Social Sciences) software package will be used to analyze the data obtained from the research. This study aims to determine the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mindfulness-Based Breathing ExerciseBreast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care. |
| Control Group | No intervention | –Breast cancer patients receiving chemotherapy who will receive routine care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over 18 years of age
Key exclusion criteria (1 listed)
- Patients with communication problems • Patients with psychiatric problems
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 Breathing ExerciseMindfulness-based breathing exercises focusing attention on breathing to promote awareness and support symptom management in breast cancer patients receiving chemotherapy. | Behavioural | Experimental Group |
Primary outcome
Symptom Severity
Time frame: Baseline and after the intervention period (e.g., 8 weeks)
Evaluation of symptom severity in breast cancer patients receiving chemotherapy using the Edmonton Symptom Assessment Scale (ESAS).
1 secondary outcome
Salivary Cortisol Level
Time frame: Baseline and after the intervention period (e.g., 8 weeks)
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 16 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Breathing Exercise in people with Breast Cancer, run by Firat University at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity (time frame: Baseline and after the intervention period (e.g., 8 weeks)). 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 16 Mar 2026.