search
Back to results

Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster

Primary Purpose

Lung Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Cycle of Breathing Techniques
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Neoplasms focused on measuring Active Cycle of Breathing Techniques, Lung Neoplasms, Symptom Cluster, Nursing, Care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active Cycle Of Breathing Techniques Group

    Control group

    Arm Description

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

    No intervention will be given to the patients in the control group.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    May 25, 2023
    Sponsor
    Maltepe University
    Collaborators
    Saglik Bilimleri Universitesi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05879354
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 10, 2023 (Anticipated)
    Primary Completion Date
    May 30, 2024 (Anticipated)
    Study Completion Date
    May 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maltepe University
    Collaborators
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Neoplasms
    Keywords
    Active Cycle of Breathing Techniques, Lung Neoplasms, Symptom Cluster, Nursing, Care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Cycle Of Breathing Techniques Group
    Arm Type
    Experimental
    Arm Description
    Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention will be given to the patients in the control group.
    Intervention Type
    Other
    Intervention Name(s)
    Active Cycle of Breathing Techniques
    Intervention Description
    Patients in the intervention group will be provided with video-guided Active Cycle of Breathing Techniques twice a day for 28 days.
    Primary Outcome Measure Information:
    Title
    Dyspnea Level
    Description
    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.
    Time Frame
    28 Days
    Title
    Fatigue Level
    Description
    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.
    Time Frame
    28 days
    Title
    Health-related quality of life in chronic cough
    Description
    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.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doğa Ulcay, Msc
    Phone
    +905302285038
    Email
    dogaulcay@maltepe.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Semiha Akın, Prof.
    Phone
    +902167779317
    Email
    semihaakin@sbu.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Doğa Ulcay, Msc
    Organizational Affiliation
    Maltepe University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Semiha Akın, Prof.
    Organizational Affiliation
    University of Health science
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Akın Öztürk, Specialist
    Organizational Affiliation
    Süreyyapaşa Chest Diseases and Thoracic Surgery Training And Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster

    We'll reach out to this number within 24 hrs