The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer:A Real World Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Change from Baseline meatal state on GAD-7 at Week 48.
研究概览
简要总结
The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:
- Patients with advanced breast cancer need family companionship
- Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast cancer patients who are pathologically or cytologically diagnosed as cancer
- •TNM clinical stage IV
排除标准
- •Terminal cancer patients who are mentally ill or confused and refuse to participate in the survey
研究组 & 干预措施
accompanying group
干预措施: Graded companionship (Behavioral)
non-accompanied group
结局指标
主要结局
Change from Baseline meatal state on GAD-7 at Week 48.
时间窗: Baseline and Week 48
The GAD-7 is a validated, self-reported instrument assessing average mental state intensify over the past 24 hour period. Possible scores range from 0 to 21.Change = (Week 48 Score - Baseline Score)
Change from Baseline physical state on kps at Week 48.
时间窗: Baseline and Week 48
The kps is a validated, self-reported instrument assessing physical state average intensify over the past 24 hour period. Possible scores range from 0 to 100.Change = (Week 48 Score - Baseline Score)
次要结局
未报告次要终点
研究者
Xin Peng
Deputy chief nurse
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology