Clinical trial NCT05879354: Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster
Official title: Investigation of the Effect of Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Keywords: Active Cycle of Breathing Techniques
Lung Neoplasms
Symptom Cluster
Nursing
Care
Lead sponsor: Maltepe University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2023-05-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dyspnea Level
timeFrame: 28 Days
measure: Fatigue Level
timeFrame: 28 days
measure: Health-related quality of life in chronic cough
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maltepe University
name: Doğa Ulcay, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health science
name: Semiha Akın, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Süreyyapaşa Chest Diseases and Thoracic Surgery Training And Research Hospital
name: Akın Öztürk, Specialist
role: PRINCIPAL_INVESTIGATOR
References: