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临床试验/NCT06910917
NCT06910917已完成不适用

Yeni Tanı Almış Meme Kanseri Hastalarına Uygulanan Roy Adaptasyon Temelli Hemşirelik Müdahalelerinin Psikolojik Dayanıklılık ve Psikososyal Uyum Üzerine Etkisi

Aytuğ Türk1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR)

研究概览

简要总结

Today, cancer has become a multifaceted problem whose diagnosis and treatment should be handled multidisciplinarily. In addition to being a medical-physical disease, cancer is a chronic phenomenon that involves many mental and psychosocial problems. Cancer patients develop various and different emotional, psychological and behavioral reactions during diagnosis, treatment, relapse and palliative periods. For this reason, holistic treatment and care of cancer patients should include medical, psychiatric and psychosocial dimensions together. Oncology, CLP and psychiatry nurses, who are important members of the team, have important duties in this regard. Accordingly, the study will be conducted with female individuals who applied to Ege University Tulay Aktas Oncology Hospital Psychooncology unit and were diagnosed with breast cancer within 6 months. The quasi-experimental method with pre-test post-test control group was used as the research method. In this context, the patients who applied to the relevant unit will be divided into two groups as experimental and control groups by simple randomization according to the order of application. SPSS 22 package program will be used in the evaluation of the data; statistical significance will be examined at 0.05 significance level. After the research groups are formed, a six-session interview program will be created for the participants in the experimental group. In the sessions, the most appropriate interventions based on the Roy Adaptation Model and the Nursing Interventions Classification System (Nursing Interventions Classification), including psychoeducation, adaptation to change, relaxation exercises, awareness, effective coping, problem solving, will be carried out for the negative situations that the disease and the disease may cause. At the end of each session, the evaluation of the interventions will be made according to the Nursing Outcomes Classification System. Individuals in the control group will not receive any intervention. The sub-concepts such as adaptation, stimulus, and behavior, which are considered and evaluated together within the conceptual framework of the Roy Adaptation model, are considered to be a highly suitable model for increasing psychosocial adaptation and psychological resilience in women newly diagnosed with breast cancer. The study data will be collected using the Individual Identification Form, Psychosocial Adjustment to Illness - Self-Report Scale and Psychological Resilience Scale. In addition to these scales that provide quantitative data, it is aimed to keep a researcher's diary during the sessions conducted by the researcher and to provide supportive data both for the evaluation of the needs and adaptation levels of the participants during the application process and for the evaluation of the application.

详细描述

Breast cancer is one of the most common cancers among women in terms of incidence and mortality rates and continues to be a major public health problem that poses a threat to women's health. According to 2020 statistics, female breast cancer has overtaken lung cancer as the most commonly diagnosed cancer. With 19.3 million new cases and 10.0 million deaths in 2020, compared to 18.1 million cases and 9.6 million deaths in 2018, the global cancer burden is increasing.

With this rise in breast cancer incidence, patients are exposed to many treatment methods and their side effects, such as hormonal drugs, surgical interventions, radiotherapy and chemotherapy, which cause intense stress due to the development of new treatment methods needed. Depending on the stage of the disease and individual characteristics of patients with breast cancer, several of these treatments may be preferred at the same time. Patients are exposed to many systemic effects of these interventions and treatment toxicity. While the aim of these treatments is to prolong the life of the patients and enable them to live with better quality of life, the physical, psychological, social well-being and daily vital functions of the patients may be negatively affected due to the prolonged duration of the interventions and the occurrence of systemic toxic effects. In addition to its high incidence, breast cancer is a serious disease due to its physical, psychological and emotional effects on women. It is important to identify and meet the information needs of women in this situation. Meeting these needs can improve the quality of life of these women by increasing their adaptation to the disease, improving their coping skills, accelerating their return to daily life, and reducing their anxiety and depression.

This long treatment process in breast cancer treatment involves a chronic recovery process that includes physical deficiencies, psychological, occupational and sexual problems, with periods of recovery and exacerbation, creating short and long-term adaptation difficulties. In the literature, there are studies indicating that many of the symptoms seen after chemotherapy can be significantly reduced by counseling, education, care and coaching practices given to patients, and that this can be provided by nurses who are in constant communication with patients. The main goal of the supportive role of the nurse is to help patients understand, cope with and adapt to distressing situations. It is very important for nurses to provide holistic care to women diagnosed with breast cancer, to address all the problems experienced by the patient and to provide counseling for them. Psychiatric and psychosocial care and treatment in patients with medical illnesses are reported to improve patient care and quality, reduce mortality and morbidity, decrease hospitalization time and general costs, and contribute to improvement and well-being. Developing the ability to recognize behaviors that indicate the presence of psychosocial problems and to manage them effectively will not only contribute to the well-being of patients, but also increase the motivation of nurses to address and intervene in psychosocial problems.

One of the many methods used for holistic care is interventions using models in practice. The Roy Adaptation Model (RAM), which is one of the widely used models in nursing, sees the person as a bio-psychosocial being in constant interaction with a changing environment. The environment includes focal, contextual and residual stimuli. The focal stimulus is the person's confrontation with the internal and external environment. The individual immediately resists these internal and external stimuli. Nurses aim to manage the focal stimulus first and then the contextual stimuli. Contextual stimuli are other stimuli that contribute to the focal stimuli and affect the current situation. Residual stimuli are implicit factors that influence the current situation. These are beliefs, behaviors and personal experiences. In the Roy Adaptation Model, which argues that nurses make interventions that facilitate the individual's adaptation to the environment, four different areas of adaptation are defined. These areas are physiological domain, self-concept domain, role function domain and interdependence domain. In these four adaptation domains, the nurse aims to improve the patient's interaction with the environment, develop adaptive behaviors and adapt to non-adaptive behaviors.

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
None

入排标准

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

入选标准

  • •Being a female aged 18 or older
  • •Having a confirmed breast cancer diagnosis within 0-6 months through clinical imaging and pathological examination
  • •Not having undergone surgery since the diagnosis or not having surgery planned within the study period (approximately 2 months) to exclude the impact of nursing care during surgical procedures

排除标准

  • •Non-primary breast cancer
  • •Presence of metastasis
  • •Receiving psychosocial treatment or therapy support
  • •Inability to attend sessions regularly
  • •Use of psychiatric medication within the last three months
  • •Having a low level of compliance

研究组 & 干预措施

Roy Adaptation Model-Based Nursing Interventions Group

Experimental

A six-session program based on the Roy Adaptation Model was implemented for the experimental group, focusing on psychosocial adaptation (physiological, self-concept, role function, interdependence). Standard nursing interventions from NIC were applied, including enhancing coping, self-esteem, body image, and functional abilities. Outcomes were evaluated using NOC, and interventions were adjusted accordingly.

干预措施: Roy Adaptation-Based Nursing Interventions (Behavioral)

Control Group (without any intervention)

No Intervention

Description: The control group received standard nursing care without additional interventions based on the Roy Adaptation Model. Their outcomes were monitored for comparison with the experimental group.

结局指标

主要结局

Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR)

时间窗: Baseline (pre-test) and 6 weeks after the intervention (post-test)

After obtaining the necessary permissions, women who participated in the study between December 2022 and November 2023 were provided with detailed face-to-face explanations about the research, and their written informed consent was obtained. The volunteers completed the scale forms in the hospital's psycho-oncology unit during six sessions, each lasting approximately 25-30 minutes.

次要结局

  • Psychological Resilience Scale (PRS)(Baseline (pre-test) and 6 weeks after the intervention (post-test))

研究者

发起方
Aytuğ Türk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aytuğ Türk

Dr.

Muğla Sıtkı Koçman University

研究点 (1)

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