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NCT Number: NCT07474337

The Effect of Mindfulness-Based Breathing Exercises on Symptom Control

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gül DURAL

Elâzığ, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gül DURAL, pHD

CONTACT

[email protected]

04242370000

Gül DURAL, pHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Breathing Exercise

Behavioral

Mindfulness-based breathing exercises focusing attention on breathing to promote awareness and support symptom management in breast cancer patients receiving chemotherapy.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

The Effect of Mindfulness-Based Breathing Exercises on Symptom Control and Salivary Cortisol Levels in Breast Cancer Patients Undergoing Chemotherapy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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