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临床试验/NCT05470543
NCT05470543已完成不适用

Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being Among Primary Caregivers of Women With Breast Cancer: A Pragmatic Parallel Group Randomized Controlled Trial

Izmir Bakircay University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Zarit Burden Interview (ZBI)

研究概览

简要总结

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. Women may experience many different physiological and psychological symptoms (such as pain, nausea-vomiting, fatigue, stress, anger, and isolation) during diagnosis and treatment process. Family members often become caregivers at the time of diagnosis, and treatment of breast cancer patients. Therefore, family caregivers experience burden and poor health-related quality of life.

详细描述

This a pragmatic, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on caregiver burden and well-being among primary caregivers of women with breast cancer. This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All primary caregivers were family members.

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

  • Being the primary caregiver of breast cancer patients
  • Able to understand and complete the questionnaires
  • Willingness to participate in the study

排除标准

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

结局指标

主要结局

Zarit Burden Interview (ZBI)

时间窗: Change from baseline Zarit Burden Interview score at 9th weeks.

The ZBI is a measure of caregiving burden developed by Zarit et al. (1980). The Turkish version of this scale has been validated by Inci and Erdem (2018). It consists of 22 items, and responses are recorded on a five-point Likert scale. The level of caregiver burden can be ascertained based on the total scale scores, which range from 0 to 88. Higher scores indicate a higher level of caregiver burden.The Cronbach's α of the Turkish version of this scale was 0.91 in Inci and Erdem (2018) validation study

次要结局

  • Caregiver Well-Being Scale(Change from baseline Caregiver Well-Being Scale score at 9th weeks.)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pinar Zorba Bahceli, PhD RN

Assistant Professor

Izmir Bakircay University

研究点 (2)

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