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Effect of Nurse-led Supportive Care on Quality of Life

2022年6月29日 更新者:Pinar Zorba Bahceli, PhD RN、Izmir Bakircay University

Effect of Nurse-led Supportive Care on Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. The several methods are used in the treatment of breast cancer. One or more of these methods can be preferred according to the characteristics of women with breast cancer. Women may experience many different physiological and psychological symptoms during each treatment process.This situation negatively affects the quality of life of women with breast cancer. For this reason, there is a need for an intervention that could improve quality of life in women with breast cancer. In the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.

研究概览

地位

完全的

条件

详细说明

This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer. This trial was conducted in the general surgery clinic of training and research hospital located in Turkey. All patients were women who had breast surgery.

研究类型

介入性

注册 (实际的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Izmir、火鸡、35560
        • Izmir Bakircay University Health Sciences Faculty

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 18 years and older women,
  • Stages II or III breast cancer
  • Having breast cancer surgery
  • Planned to receive chemotherapy
  • Able to use a phone
  • Who agreed to participate in the study

Exclusion Criteria:

  • Having communication problems
  • Having psychological diseases
  • Receiving any supportive care

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:护士主导的支持治疗小组
Nurse-led supportive care was given to women who had breast surgery and planned to receive chemotherapy. Nurse-led supportive care was applied to women for eight weeks in the form of face-to-face clinic and telephone interviews.It took an average of 30 minutes to interview women with breast cancer at the clinic, and 15 minutes on average by phone.
无干预:控制组
对照组在研究期间没有接受任何干预。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)
大体时间:Change from Baseline Quality of Life score at 9th weeks.
The scale was developed to assess the quality of life of cancer patients. It contains three domains that measure global health status/quality of life, functional and symptom status. Global quality of life is assessed using global health status and quality of life. Functional status consists of the following five subscales: physical function, role function, emotional function, cognitive function and social function. Symptom status consists of the following nine subscales: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties. The total score that can be obtained from the scale ranges from 0 to 100. The internal consistency of scale in the Turkish version was determined as 0.90.
Change from Baseline Quality of Life score at 9th weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年1月3日

初级完成 (实际的)

2022年5月30日

研究完成 (实际的)

2022年6月10日

研究注册日期

首次提交

2022年5月24日

首先提交符合 QC 标准的

2022年5月28日

首次发布 (实际的)

2022年6月1日

研究记录更新

最后更新发布 (实际的)

2022年6月30日

上次提交的符合 QC 标准的更新

2022年6月29日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2021/270

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

生活质量的临床试验

Nurse-led Supportive Care的临床试验

3
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