Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Neoplasms
• Intervention / Treatment: Other: Active Cycle of Breathing Techniques

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doğa Ulcay, Msc; Phone Number: +905302285038; Email: dogaulcay@maltepe.edu.tr
• Study Contact Backup: Name: Semiha Akın, Prof.; Phone Number: +902167779317; Email: semihaakin@sbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Cycle Of Breathing Techniques Group; Patients 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; Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days.
No Intervention: Control group; No intervention will be given to the patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Maltepe University
• Collaborators: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Doğa Ulcay, Msc, Maltepe University; Principal Investigator: Semiha Akın, Prof., University of Health science; Principal Investigator: Akın Öztürk, Specialist, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Nursing; Care; Lung Neoplasms; Active Cycle of Breathing Techniques; Symptom Cluster
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease; Respiratory Tract Neoplasms; Thoracic Neoplasms; Syndrome; Lung Neoplasms
• Other Study ID Numbers: MAU_DogaUlcay_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No