跳至主要内容
临床试验/NCT05937425
NCT05937425已完成不适用

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 University2 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2023年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Depression, Stress, Anxiety Scale (DASS21)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Depression, Stress, Anxiety Scale (DASS21)

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Müge ALTINIŞIK

MSc, Research Assistant

Akdeniz University

研究点 (2)

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