NCT07474337

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 10, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Mindfulness-Based BreathingSymptom ManagementSalivary CortisolNon-Pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Symptom Severity

    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 Outcomes (1)

  • Salivary Cortisol Level

    Baseline and after the intervention period (e.g., 8 weeks)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Breast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care.

Behavioral: Mindfulness-Based Breathing Exercise

Control Group

NO INTERVENTION

Breast cancer patients receiving chemotherapy who will receive routine care only.

Interventions

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

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with communication problems • Patients with psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gül DURAL

Elâzığ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations