The Effect of Nurse Navigation Program on Lung Cancer Patients

NCT ID: NCT05937425

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2024-11-06

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Effects of nurse navigation program on patients with lung cancer

Group Type: EXPERIMENTAL

LungCaNN

Intervention Type: OTHER

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.

Control group

An information note will be given to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Müge ALTINIŞIK

MSc, Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Arikan, PhD, RN

Role: STUDY_DIRECTOR

Akdeniz University

Locations

Akdeniz University

Konyaalti, Antalya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

240778

Identifier Type: -

Identifier Source: org_study_id