The Effect of Nurse Navigation Program on Lung Cancer Patients ([LungCaNN])

January 27, 2025 updated by: Müge ALTINIŞIK, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Antalya
      • Konyaaltı, Antalya, Turkey, 07070
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Effects of nurse navigation program on patients with lung cancer
Other: LungCaNN
The needs of the patients included in the study will be determined with the supportive care needs scale. A training booklet will be given to the patients in the intervention group and they will be informed about the existing or newly formed unsupported care needs, the evaluation of their frequency and severity, and the ability of the patients to call the navigator nurse 24/7 or send an SMS. For interventions that can be applied in line with evidence-based guidelines for unsupported care needs with patients included in the intervention group every week for 12 weeks, a face-to-face navigation will be made by the navigator nurse over the phone and once a month.
No Intervention: Control group
An information note will be given to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline DASS21 at 12 week
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.
change from baseline EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module at 12 week
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.
change from baseline Scale of Adjustment to Chronic Diseases at 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Fatma Arikan, PhD, RN, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240778

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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