Effect of Breathing Exercises on Pain, Dyspnea, and Function in Terminal-Stage Cancer Patients

NCT ID: NCT07164352

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-04

Study Completion Date

2025-05-15

Brief Summary

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This study aims to evaluate the effects of supervised breathing exercises on pain, dyspnea, and functionality in terminal-stage cancer patients receiving palliative care. Participants in the intervention group receive diaphragmatic and pursed-lip breathing exercises under the guidance of a physiotherapist, while the control group receives only an educational brochure. The study compares pre- and post-intervention outcomes between both groups.

Detailed Description

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This randomized controlled trial aims to investigate the effects of diaphragmatic and pursed-lip breathing exercises on pain, dyspnea, and functional status in terminal-stage cancer patients receiving palliative care. Participants are divided into two groups: the intervention group receives supervised breathing exercises by a physiotherapist, while the control group is given an informational brochure without any physical guidance.

The primary objective is to determine whether supervised breathing exercises provide significant improvements in symptom control and functionality compared to usual care. Assessments are made before and after the intervention using validated tools including the Edmonton Symptom Assessment System (ESAS-r), the Cancer Dyspnea Scale (CDS), and the Visual Analog Scale (VAS) for pain.

The study aims to contribute to the clinical evidence supporting non-pharmacological interventions in palliative care and to offer practical approaches for improving quality of life in terminally ill cancer patients.

Conditions

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Palliative Patients Terminal Malignant Tumors Breathing Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist

Participants in this arm receive supervised breathing exercises performed with a physiotherapist, focusing on diaphragmatic and pursed-lip breathing techniques.

Group Type EXPERIMENTAL

Breathing Exercises

Intervention Type BEHAVIORAL

Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist.

Brochure Education Only

Participants in this arm receive an informational brochure that explains breathing exercises, but no supervised exercise is provided.

Group Type ACTIVE_COMPARATOR

Informational Brochure

Intervention Type BEHAVIORAL

A brochure providing education about breathing exercises for cancer patients.

Interventions

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Breathing Exercises

Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist.

Intervention Type BEHAVIORAL

Informational Brochure

A brochure providing education about breathing exercises for cancer patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients receiving palliative care, who are part of this treatment process and considered eligible for the study.
* Patients diagnosed with Stage 4 cancer, included in the study due to their advanced cancer stage.
* Patients with oxygen saturation levels below 95% in room air, who are deemed appropriate for monitoring respiratory function due to this condition.
* Participants must be able to effectively communicate during the study period.
* Individuals who agree to participate in the study must provide written or verbal consent, which is a mandatory criterion for ethical compliance.

Exclusion Criteria

* Patients who are unconscious and unable to participate in the study. Individuals under the age of 18.
* Patients dependent on a ventilator.
* Patients with serious health issues, such as uncontrolled hypertension and dyspnea.
* Patients with other significant health problems that prevent participation in the research program.
* Patients with medical conditions requiring drainage treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlas University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Nur Yildiz

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaşar Gül BALTACI, Prof. Dr.

Role: STUDY_DIRECTOR

İstanbul Atlas University, Department of Physical Medicine and Rehabilitation

Locations

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Eyupsultan State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ATLAS-FTR-FNY-01

Identifier Type: -

Identifier Source: org_study_id

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