- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520799
The Effect of Mindfulness-Based Breathing Exercises on Dyspnea, Symptom Control, and Quality of Life in Lung Cancer Patients Undergoing Chemotherapy
The Effect of Mindfulness-Based Breathing Exercises in Lung Cancer Patients Undergoing Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Elâzığ, Center, Turkey (Türkiye), 25240
- Fırat university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Individuals with communication problems
- Individuals with psychiatric problems
- Patients who engage in any kind of exercise
- Will not be included in Phase 4 studies
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Breathing Exercises
The group where the application was made
|
Mindfulness-Based Breathing Exercises
|
|
No Intervention: Control group
The group where the application was not made
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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."
|
8 week
|
|
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.
|
8 week
|
|
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. |
8 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/02-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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