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临床试验/NCT06949046
NCT06949046已完成不适用

Effects of a Nursing-led Communication Support Program Using Mobile Health Information on Physical and Mental Status in Breast Cancer Patients Undergoing Concurrent Chemotherapy: a Randomized Controlled Trial

National Defense Medical Center, Taiwan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月1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
80
试验地点
1
主要终点
Quality of Life (EORTC QLQ-C30)

研究概览

简要总结

Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.

详细描述

The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •breast cancer initial chemotherapy

排除标准

  • •Patients whose cancer has recurred without undergoing the first course of chemotherapy

研究组 & 干预措施

Nursing routine treatment

Placebo Comparator

Nursing routine treatment

干预措施: Nursing routine treatment (Other)

nursing-led communication

Experimental

nursing-led communication support

干预措施: nursing-led communication support (Other)

结局指标

主要结局

Quality of Life (EORTC QLQ-C30)

时间窗: Baseline, 1 month, and 2 months after enrollment

Quality of life was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores were transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores indicate better functioning and global quality of life, whereas higher symptom scores indicate greater symptom burden. Measurements were obtained at baseline, 1 month, and 2 months after enrollment.

次要结局

  • Anxiety and Depression(Baseline, 1 month, and 2 months after enrollment)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei Man

Student

National Defense Medical Center, Taiwan

研究点 (1)

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