Lung CancerNCT07520799
The Effect of Mindfulness-Based Breathing Exercises on Dyspnea, Symptom Control, and Quality of Life in Lung Cancer Patients Undergoing Chemotherapy
A study testing Mindfulness-Based Breathing Exercises in people with Lung Cancer, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Mindfulness-Based Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Nov 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with communication problems
- Individuals with psychiatric problems
- Patients who engage in any kind of exercise
- Will not be included in Phase 4 studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mindfulness-Based Breathing Exercises in Lung Cancer Patients Undergoing Chemotherapy
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.
- Conditions
- Lung Cancer
- Being tested
- Mindfulness-Based Breathing Exercises
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Breathing ExercisesBehavioural
Mindfulness-Based Breathing Exercises
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Breathing Exercises | Experimental | The group where the application was made Receives: Behavioral: Mindfulness-Based Breathing Exercises |
| Control group | No intervention | The group where the application was not made |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520799
- Sponsor's protocol ID
- 2026/02-04
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Breathing Exercises in Lung Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07520799
- Acronym / sponsor ID
- 2026/02-04
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Apr 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Breathing Exercises | Experimental | Behavioral: Mindfulness-Based Breathing ExercisesThe group where the application was made |
| Control group | No intervention | –The group where the application was not made |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Individuals with communication problems
- Individuals with psychiatric problems
- Patients who engage in any kind of exercise
- Will not be included in Phase 4 studies
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 ExercisesMindfulness-Based Breathing Exercises | Behavioural | Mindfulness-Based Breathing Exercises |
Primary outcome
Edmonton Symptom Assessment Scale:
Time frame: 8 week
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."
EORTC QLQ-C 30 Quality of Life Scale
Time frame: 8 week
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.
DYSPNEA-12 TR SCALE
Time frame: 8 week
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.
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 14 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercises in people with Lung 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Symptom Assessment Scale: (time frame: 8 week). The study lists 3 primary outcomes in all. 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 14 Apr 2026.