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临床试验/NCT05360407
NCT05360407已完成不适用

The Effect of Mobile Application-based Information About Before and After Surgery on Anxiety, Distress and Quality of Life of Women With Breast Cancer

Suleyman Demirel University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年4月1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
82
试验地点
2
主要终点
Change of NCCN Distress Thermometer score at baseline and one month later

研究概览

简要总结

Aim and hypothesis: This study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. E-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (I) and the level of distress (II), and positively affects their quality of life (III).

Methods: This randomized controlled study was conducted between April and August 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. Patients in the intervention group (n=42) used the mobile information application for one month with routine care. Patients in the control group (n=40) received their routine care. Data were collected with data collection forms one week before and three weeks after surgery.

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

入选标准

  • Scheduled for elective surgery due to breast cancer,
  • Over 18 years old,
  • Read and understand Turkish,
  • At least primary school graduates,
  • Have internet access,
  • Have a smartphone with an android operating system suitable for downloading the mobile application.

排除标准

  • Diagnosed with active psychiatric disease,
  • Using antidepressant medication,
  • Vision problems that prevented them from using the mobile application,
  • Scheduled for reconstructive surgery using their own tissue

结局指标

主要结局

Change of NCCN Distress Thermometer score at baseline and one month later

时间窗: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.

This scale was developed by Roth et al. (1998) to measure psycho-social distress in cancer patients. It consists of the visual analog scale that individuals can apply on their own, consists of only one question, and is used to evaluate the stress situations patients have experienced in the last week and a list of problems. There is a thermometer with numbers from 0 to 10 on the scale. On the distress thermometer, a score of 0 indicates that the individual has never experienced distress, and a score of 10 indicates that he or she has experienced distress at the upper limit.

次要结局

  • Change of FACT-G Quality of Life Scale score at baseline and one month later(The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.)
  • Change of Hospital Anxiety and Depression Scale score at baseline and one month later(The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.)

研究者

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

Filiz Salman

Principal Investigator

Suleyman Demirel University

研究点 (2)

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