NCT07520799

Brief Summary

This research is designed to determine the effect of mindfulness-based breathing exercises on dyspnea, symptom control, and quality of life in lung cancer patients undergoing chemotherapy. Lung cancer is a disease with a high mortality rate and a heavy symptom burden, and symptoms such as dyspnea, fatigue, pain, anxiety, and sleep problems are frequently observed during chemotherapy. Dyspnea, in particular, is one of the main symptoms that has both physical and emotional dimensions and significantly negatively affects patients' daily living activities, adherence to treatment, and quality of life. Therefore, integrating non-pharmacological and complementary nursing interventions into the care process in addition to pharmacological approaches is important. Mindfulness-based breathing exercises are a structured application that aims to regulate the respiratory rhythm, increase relaxation, and reduce symptom perception by enabling the individual to focus on their breath and bodily sensations without judgment. The research will be conducted using a pre-test-post-test control group experimental design. The study will be carried out with lung cancer patients receiving chemotherapy at Gazi Yaşargil Training and Research Hospital between April 2026 and September 2026. The study sample will consist of a total of 60 patients (30 experimental, 30 control) who meet the inclusion criteria and voluntarily agree to participate. Randomization will be used to determine the groups. Patients in the intervention group will receive a mindfulness-based breathing exercise program for eight weeks. The first four weeks will consist of 20-30 minute face-to-face individual training sessions once a week, followed by four weeks of 15-20 minute exercises at home twice a week. The control group will receive no intervention other than routine care. Data will be collected before and eight weeks after the intervention using a Personal Information Form, the Edmonton Symptom Assessment Scale, the EORTC QLQ-C30 Quality of Life Scale, and the Dyspnea-12 TR Scale. Frequency, percentage, mean, and standard deviation will be calculated for data analysis; chi-square test, independent samples t-test, and dependent samples t-test will be used for intergroup comparisons. This study is expected to provide evidence-based contributions to nursing care by demonstrating the effectiveness of mindfulness-based breathing exercises in reducing dyspnea and symptom burden and improving quality of life in lung cancer patients undergoing chemotherapy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress25%
May 2026Nov 2026

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 3, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Edmonton Symptom Assessment Scale:

    The Edmonton Symptom Assessment Scale was developed by Bruera et al. to assess .nine common symptoms in cancer patients (Çalışkan, Gürhan, and Tekgündüz, 2017). The scale includes nine symptoms: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, malaise, and shortness of breath. In the Turkish validity and reliability study conducted by Sadırlı (2008), skin and nail changes, mouth sores, and numbness in the hands were added to the original scale. Each symptom is evaluated on a numerical scale from 0 to 10. A score of 0 indicates that the symptom is not experienced at all; a score of 10 indicates that the symptom is experienced at its most severe level. The basic principle of the scale is that the patient makes their own assessment. Patients are asked to indicate the number that they think best reflects the severity of the symptom they are experiencing."Higher scores on the Edmonton Symptom Assessment Scale indicate greater symptom severity."

    8 week

  • EORTC QLQ-C 30 Quality of Life Scale

    The EORTC QLQ-C30 Quality of Life Scale was developed in 1987 by the European Organization for Cancer Treatment and Research (EORTC) to assess the quality of life of cancer patients and was later revised by Aaronson et al. (Jameson et al., 2018). The adaptation of the scale to the Turkish population and the validity-reliability study were carried out by Güzelant et al., and the Cronbach alpha coefficient was found to be 0.70.

    8 week

  • DYSPNEA-12 TR SCALE

    The Dyspnea-12 scale was developed by Yorke et al. to assess both the physical and emotional dimensions of dyspnea symptoms and was published in 2011 (Yorke et al., 2011). Consisting of 12 items, the scale has a four-point Likert-type response system, with each item scored from 0 to "none", 1 to "mild", 2 to "moderate", and 3 to "severe". The first seven items of the scale are aimed at evaluating the physical symptoms related to dyspnea. Through these items, physical symptoms such as difficulty breathing, insufficient air reaching the lungs, and increased effort required during breathing are investigated. The remaining five items of the scale evaluate the effects of shortness of breath on the individual's emotional state; focusing on emotional responses such as stress, irritability, depressive mood, general distress, and restlessness.Higher scores on the Dyspnea-12 indicate greater severity of breathlessness.

    8 week

Study Arms (2)

Mindfulness-Based Breathing Exercises

EXPERIMENTAL

The group where the application was made

Behavioral: Mindfulness-Based Breathing Exercises

Control group

NO INTERVENTION

The group where the application was not made

Interventions

Mindfulness-Based Breathing Exercises

Mindfulness-Based Breathing Exercises

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age
  • Being able to communicate adequately
  • Not having a psychiatric problem
  • Those whose physical condition preventing them from exercising has been determined by a physician
  • Patients who have completed at least 4 courses

You may not qualify if:

  • Individuals with communication problems
  • Individuals with psychiatric problems
  • Patients who engage in any kind of exercise
  • Will not be included in Phase 4 studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations