The Effect of Mindfulness-Based Breathing Exercises on Symptom Control

March 11, 2026 updated by: Gui Dural, Firat University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Elâzığ, Turkey (Türkiye)
        • Recruiting
        • Gül DURAL
        • Contact:
        • Principal Investigator:
          • Gül DURAL, pHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with communication problems • Patients with psychiatric problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Breast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care.
Behavioral: Mindfulness-Based Breathing Exercise
Mindfulness-based breathing exercises focusing attention on breathing to promote awareness and support symptom management in breast cancer patients receiving chemotherapy.
No Intervention: Control Group
Breast cancer patients receiving chemotherapy who will receive routine care only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and after the intervention period (e.g., 8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary Cortisol Level
Time Frame: Baseline and after the intervention period (e.g., 8 weeks)
Assessment of stress level by measuring salivary cortisol levels in breast cancer patients undergoing chemotherapy.
Baseline and after the intervention period (e.g., 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/15-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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