Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster

Lung Neoplasms Clinical Trial

Official title:

Investigation of the Effect of Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster in Patients With Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05879354
• Other study ID #: MAU_DogaUlcay_001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2023
• Source: Maltepe University
• Contact: Doga Ulcay, Msc
• Phone: +905302285038
• Email: dogaulcay[@]maltepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Syndrome

Intervention

Other:
• Active Cycle of Breathing Techniques
Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maltepe University	Saglik Bilimleri Universitesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 Days
Primary	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.	28 days
Primary	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.	28 days