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临床试验/NCT05571098
NCT05571098已完成不适用

The Effects of Nurse Navigation Program on Symptom Management and Psychosocial Adjustment Applied to Patients With Colorectal Cancer

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月8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
60
试验地点
1
主要终点
Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group.

研究概览

简要总结

This study was conducted to examine the effect of the nurse navigation program (NNP) applied to patients with colorectal cancer on symptom management and psychosocial adjustment to the disease. The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements. For this purpose, individuals were divided into two groups as experimental (n=31) and control (n=31) groups. The study was carried out in Istanbul Lütfi Kırdar City Hospital Oncology Clinic between July 2021 and February 2022, after the necessary permissions were obtained. While individualized colorectal cancer education, psycho-oncological counseling and telephone support services were provided to the individuals in the experimental group under the guidance of nurse within the scope of NNP, no intervention was applied to the control group. In the study, data were collected with three different data collection tools: "Information Form", "Nightingale Symptom Assessment Scale (N-SAS)", "Psychosocial Adjustment To Illness Scale (PAIS/PAIS-SR)". Data were collected before NNP (once in the first week after chemotherapy), during NNP (once in the second week after chemotherapy, once in the first week after the next chemotherapy), after NNP (once in the second week after the next chemotherapy). The duration of the interventions performed via the WhatsApp application varied between 45-60 minutes between individuals. The research was completed with a total of 60 individuals, 30 in the experimental group and 30 in the control group. The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

详细描述

Cancer is a leading cause of death worldwide, accounting for approximately 10 million deaths or one in six deaths in 2020 (WHO, 2022). According to cancer data published by GLOBOCAN 2020, colorectal cancer is the third most common cancer and the second most common cause of death among all cancer types (GLOBOCAN, 2020). Cancer, the incidence of which is increasing day by day, can cause serious mental problems and psychological effects in the social life of patients, as well as physical difficulties, and this situation negatively affects the course of the disease (Ülger et al, 2014). When the relevant literature is examined for colorectal cancer patients, pain, nausea, vomiting, impaired bowel function, anorexia and delirium are the most common symptoms in colorectal cancer patients (Kocakuşak et al, 2011; El-Shami et al, 2015). Many cancer patients experience psychosocial symptoms in addition to physical symptoms (Ülger et al, 2014). The most common psychosocial symptoms in cancer patients are usually adjustment disorders, depression, anxiety, decreased life satisfaction or loss of self-confidence (Akechi et al, 2001; Ateşci et al, 2003; Seven et al, 2013; Rashid et al, 2021). Since the treatment process of cancer includes a heavy and long process, it is important for patients to receive psycho-social support to protect their mental health and improve their ability to cope with the disease (Ülger et al, 2014). Patient navigation includes the services provided by professionals (navigators) trained in this field to provide education and support to individuals in overcoming the problems they encounter in the health care system, to encourage them to have cancer screenings, and to guide individuals (Dönmez, 2019). When the relevant literature is examined, although there are many studies on the use of navigation programs in cancer patients, no study on symptom management and psychosocial adjustment in individuals diagnosed with colorectal cancer has yet been found (Sussman et al, 2018; Loiselle et al, 2010; Nam et al, 2019; Young et al, 2010; Shum et al, 2014). In this context, the aim of this study is to examine the effect of the nurse navigation program applied to colorectal cancer patients on symptom management and psychosocial adjustment and to contribute to the relevant literature.

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 (Participant)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group.

时间窗: 33 weeks

Nightingale Symptom Assessment Scale (N-SAS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner which evaluates the severity of symptoms developing in patients with cancer and its treatment. The scale consists of 38 items in total. The scale has three sub-dimensions: Physical Well-being (items 1-4, 6-15, 23-27 and 37), Social Well-being (items 5 and 16-22) and Psychological Well-being (items 28-36 and 38). The scale is in a 5-point Likert type, and the patient's response to the evaluated item is scored as "0" if it is no, "1" if it is very little, "2" if it is a little, "3" if it is quite a lot, and "4" if it is too much. A high score indicates that the level of being affected by the disease/treatment-related problems is high (Can and Aydiner, 2011).

Psychosocial Adjustment to Illness Scale (PAIS-SR) scores should be lower in the NNP applied group than in the non-applied group.

时间窗: 33 weeks

Psychosocial Adjustment to Illness Scale (PAIS-SR) is a scale developed in English by Derogatis in 1986, aiming to evaluate psychosocial adjustment to physical illness (Deragotis, 1986). The Turkish validity and reliability study of the PAIS-SR was carried out by Adaylar (1995). The scale, which consists of 46 items, has seven sub-dimensions: compliance with health care, occupational environment, home environment, sexual relations, extended family relations, social environment, and psychosocial pressure. The lowest score that can be obtained from the scale is 0, and the highest score is 138. Scores below 35 in the scale indicate "good psychosocial adjustment", scores between 35 and 51 indicate "moderate psychosocial adjustment", and scores above 51 indicate "poor psychosocial adjustment" (Adaylar, 1995).

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

Zeynep DÜLGER

Research Assistant

Saglik Bilimleri Universitesi

研究点 (1)

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