NCT05879354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

April 13, 2023

Last Update Submit

June 18, 2025

Conditions

Keywords

Active Cycle of Breathing TechniquesLung NeoplasmsSymptom ClusterNursingCare

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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.

Other: Active Cycle of Breathing Techniques

Control group

NO INTERVENTION

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

Interventions

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

Active Cycle Of Breathing Techniques Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung NeoplasmsSyndrome

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Doğa Ulcay, Msc

    Maltepe University

    PRINCIPAL INVESTIGATOR
  • Semiha Akın, Prof.

    University of Health science

    PRINCIPAL INVESTIGATOR
  • Akın Öztürk, Specialist

    Süreyyapaşa Chest Diseases and Thoracic Surgery Training And Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 30, 2023

Study Start

October 1, 2023

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations