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Clinical Trials/NCT05937425
NCT05937425
Completed
N/A

The Effect of Nurse Navigation Program Applied in Line With Supportive Care Needs in Patients Diagnosed With Lung Cancer on Anxiety-Depression, Adaptation to the Disease and Quality of Life

Akdeniz University1 site in 1 country84 target enrollmentJune 5, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non Small Cell Lung Cancer
Sponsor
Akdeniz University
Enrollment
84
Locations
1
Primary Endpoint
Depression, Stress, Anxiety Scale (DASS21)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The study aims to determine the effect of the nurse navigation program (LungCaNN), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life.

The study was designed as a randomized study with a control group. This study will be carried out with a total of 84 NSCLC patients, 42 of whom were in the intervention group and 42 in the control group, whose treatment was started in Akdeniz University Medical Oncology Outpatient Clinic and met the inclusion criteria of the sampling. Nurse navigation program will be applied for 12 weeks from the diagnosis of NSCLC patients in the intervention group. The intervention protocol of the study is abbreviated as "Lung Cancer Nurse Navigator" [LungCaNN].

Within the scope of the LungCaNN program, face-to-face patient education, patient education booklet, face-to-face, and telephone navigation initiatives were planned. Patient Identification Form, Depression Anxiety Stress Scale (DASS 21), Chronic Disease Adjustment Scale, EORTC QLQ 30 Quality of Life Scale-/ LC-13, and Navigation and Interview Steps Form will be used to collect data.

Registry
clinicaltrials.gov
Start Date
June 5, 2023
End Date
November 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Müge ALTINIŞIK

MSc, Research Assistant

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • Know how to read and write No hearing or speech problems Be able to use the phone The primary medical diagnosis is non-small cell lung cancer Karnofsky Performance Scale score of 70% or higher Patients with a stress thermometer of 4 and above At most six weeks past the date of diagnosis

Exclusion Criteria

  • Patients with cognitive problems Expected life expectancy is less than three months

Outcomes

Primary Outcomes

Depression, Stress, Anxiety Scale (DASS21)

Time Frame: change from baseline DASS21 at 12 week

It is used to evaluate depression, stress, and anxiety levels. Each item scores between 0-3 and gives separate scores for depression, stress, and anxiety. A maximum of 21 and a minimum of 0 points can be obtained from the scales. High scores indicate high levels of depression, stress, and anxiety.

Scale of Adjustment to Chronic Diseases

Time Frame: change from baseline Scale of Adjustment to Chronic Diseases at 12 week

The scale was developed to determine the level of compliance of patients with the disease. It consists of 25 items. It consists of three sub-dimensions: Physical Adaptation, Social Adaptation, and Psychological Adaptation. The total score that can be obtained from the scale is 125. High scores from the sub-dimensions and/or the whole scale mean that the patient's level of compliance with the disease also increases.

EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module

Time Frame: change from baseline EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module at 12 week

This scale was developed to measure the quality of life of cancer patients. It includes 30 questions and three sub-dimensions: General Well-being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100 and the minimum score is 0. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life. Scoring of the Quality of Life Scale LC-13 Lung Module is also done by symptom scale scoring. A high score from the LC-13 Lung Module indicates that the symptoms are experienced intensely.

Study Sites (1)

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