Lung NeoplasmsNCT05879354
Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster
A study testing Active Cycle of Breathing Techniques in people with Lung Neoplasms, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a randomized, control group, experimental study to examine the effect of Active Cycle of Breathing Techniques application on respiratory distress symptom cluster in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Active Cycle of Breathing Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Being diagnosed with stage IV non-small cell lung cancer
- Being diagnosed with lung cancer in the type of adenocarcinoma and squamous cell carcinoma
- Receiving outpatient chemotherapy treatment
- Receiving the first course of chemotherapy treatment
- ECOG Performance Scale Score < 3
Show all 10Show fewer
- Having all the symptoms of dyspnea, cough, and fatigue
- Not having a cognitive disorder or a diagnosed psychiatric illness
- Being able to speak Turkish
- Volunteering to participate in the research
Who cannot join
- Experiencing a chronic obstructive pulmonary disease (COPD) exacerbation in the last 4 weeks
- Having an active lung infection
- Not volunteering to participate in the research
- Not having dyspnea, cough, and fatigue symptoms
- Not speaking Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: Investigation of the Effect of Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster in Patients With Lung Cancer
This study was designed as a randomized, control group, experimental study to examine the effect of Active Cycle of Breathing Techniques application on respiratory distress symptom cluster in patients with lung cancer.
Read the detailed description
The sample of the study will consist of patients who received chemotherapy treatment with the diagnosis of Stage IV non-small cell lung cancer in the outpatient chemotherapy service of a training and research hospital and met the inclusion criteria. Data in the study will be collected using the Patient Information Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale, Cancer Dyspnea Scale, Leicester Cough Questionnaire and Cancer Fatigue Scale. In order to test the applicability and comprehensibility of the forms to be used before the study, a preliminary application will be made with 5 patients. This study is planned to prepare a video describing the application for patients to use while performing the Active Cycle of Breathing Techniques application. On the 1st day of the study, a 10-minute face-to-face training will be given to the intervention (experimental) group by the researcher using the video about the Active Cycle of Breathing Techniques. In the research, the intervention (experimental) group will be asked to follow the video to be prepared and apply the Active Cycle of Breathing Techniques twice a day for 28 days. The intervention (experimental) group will be monitored by telephone call once a week and 3 times using the Patient Follow-up Form (days 7, 14 and 21). On the other hand, only the pre-test and post-test will be applied to the control group.
- Conditions
- Lung Neoplasms
- Being tested
- Active Cycle of Breathing Techniques
- Keywords
- Active Cycle of Breathing Techniques, Lung Neoplasms, Symptom Cluster, Nursing, Care
- Medical subject headings
- Lung Neoplasms, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cycle of Breathing TechniquesOther
Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Active Cycle Of Breathing Techniques Group | Experimental | Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days. Receives: Other: Active Cycle of Breathing Techniques |
| Control group | No intervention | No intervention will be given to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Level
The level of dyspnea will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Cancer Dyspnea Scale, the Turkish Validity and Reliability of which was made by Bitek and Tokem in 2021, will be used to measure the level of dyspnea.
Measured: 28 Days
Fatigue Level
The level of fatigue will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Hirai Cancer Fatigue Scale, the Turkish validity and reliability of which was made by Mencel in 2021, will be used to measure the level of fatigue.
Measured: 28 days
Health-related quality of life in chronic cough
The level of health-related quality of life in chronic cough will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Leicester Cough Questionnaire (LCQ), the Turkish validity and reliability of which was made by Gonen ve Havlucu in 2014, will be used to measure the level of health-related quality of life in chronic cough.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Oct 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Model description
- The intervention group will apply the Active Cycle of Breathing Techniques with video twice a day for 28 days and the control group will not.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Doğa Ulcay, Maltepe University
- Investigators
- Doğa Ulcay, Msc, Principal investigator, Maltepe UniversitySemiha Akın, Prof., Principal investigator, University of Health scienceAkın Öztürk, Specialist, Principal investigator, Süreyyapaşa Chest Diseases and Thoracic Surgery Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879354
- Sponsor's protocol ID
- MAU_DogaUlcay_001
- Status last verified
- Jun 2025
- First submitted
- 13 Apr 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT05879354
- Acronym / sponsor ID
- MAU_DogaUlcay_001
- Conditions
- Lung Neoplasms
- Keywords
- Active Cycle of Breathing Techniques, Lung Neoplasms, Symptom Cluster, Nursing, Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 May 2023 (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 study was designed as a randomized, control group, experimental study to examine the effect of Active Cycle of Breathing Techniques application on respiratory distress symptom cluster in patients with lung cancer.
Detailed description
The sample of the study will consist of patients who received chemotherapy treatment with the diagnosis of Stage IV non-small cell lung cancer in the outpatient chemotherapy service of a training and research hospital and met the inclusion criteria. Data in the study will be collected using the Patient Information Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale, Cancer Dyspnea Scale, Leicester Cough Questionnaire and Cancer Fatigue Scale. In order to test the applicability and comprehensibility of the forms to be used before the study, a preliminary application will be made with 5 patients. This study is planned to prepare a video describing the application for patients to use while performing the Active Cycle of Breathing Techniques application. On the 1st day of the study, a 10-minute face-to-face training will be given to the intervention (experimental) group by the researcher using the video about the Active Cycle of Breathing Techniques. In the research, the intervention (experimental) group will be asked to follow the video to be prepared and apply the Active Cycle of Breathing Techniques twice a day for 28 days. The intervention (experimental) group will be monitored by telephone call once a week and 3 times using the Patient Follow-up Form (days 7, 14 and 21). On the other hand, only the pre-test and post-test will be applied to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will apply the Active Cycle of Breathing Techniques with video twice a day for 28 days and the control group will not.
| Arm | Type | Receives |
|---|---|---|
| Active Cycle Of Breathing Techniques Group | Experimental | Other: Active Cycle of Breathing TechniquesPatients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days. |
| Control group | No intervention | –No intervention will be given to the patients in the control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being 18 years or older
- Being diagnosed with stage IV non-small cell lung cancer
- Being diagnosed with lung cancer in the type of adenocarcinoma and squamous cell carcinoma
- Receiving outpatient chemotherapy treatment
- Receiving the first course of chemotherapy treatment
Key exclusion criteria (5 listed)
- Experiencing a chronic obstructive pulmonary disease (COPD) exacerbation in the last 4 weeks
- Having an active lung infection
- Not volunteering to participate in the research
- Not having dyspnea, cough, and fatigue symptoms
- Not speaking Turkish
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 |
|---|---|---|
| Active Cycle of Breathing TechniquesPatients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days. | Other | Active Cycle Of Breathing Techniques Group |
Primary outcome
Dyspnea Level
Time frame: 28 Days
The level of dyspnea will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Cancer Dyspnea Scale, the Turkish Validity and Reliability of which was made by Bitek and Tokem in 2021, will be used to measure the level of dyspnea.
Fatigue Level
Time frame: 28 days
The level of fatigue will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Hirai Cancer Fatigue Scale, the Turkish validity and reliability of which was made by Mencel in 2021, will be used to measure the level of fatigue.
Health-related quality of life in chronic cough
Time frame: 28 days
The level of health-related quality of life in chronic cough will be lower in patients in the intervention (experimental) group to whom Active Breathing Cycle techniques were applied, compared to the patients in the control group who did not. The Turkish version of the Leicester Cough Questionnaire (LCQ), the Turkish validity and reliability of which was made by Gonen ve Havlucu in 2014, will be used to measure the level of health-related quality of life in chronic cough.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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. This study is not recruiting at the moment.
Doğa Ulcay, Msc principal investigator
Maltepe University
Semiha Akın, Prof. principal investigator
University of Health science
Akın Öztürk, Specialist principal investigator
Süreyyapaşa Chest Diseases and Thoracic Surgery Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cycle of Breathing Techniques in people with Lung Neoplasms, run by Maltepe 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dyspnea Level (time frame: 28 Days). 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 24 Jun 2025.