Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment
As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL.
The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Singapore、新加坡、169610
- National Cancer Centre Singapore
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients diagnosed with breast cancer were included if they met the following criteria:
- 21 years or older
- able to read and understand either English or Mandarin
- diagnosis of Stages 1-3 breast cancer by a medical oncologist
- completed adjuvant cytotoxic treatment
Exclusion Criteria:
- Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 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 |
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实验性的:Intervention Arm
On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed.
Patients in the PEG group will be involved in three sessions of psychoeducation.
The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.
This program is designed to take place on three individual days on a weekend.
For each session, three major topics will be covered, with lectures and interactive workshop integrated.
Sessions will be conducted by healthcare professionals who are experts/well-versed in their respective domains.
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On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed.
Patients in the PEG group will be involved in three sessions of psychoeducation.
The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.
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安慰剂比较:Usual Care
No active intervention provided.
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日常护理
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Severity of anxiety, as measured using Beck Anxiety Inventory
大体时间:Within one month after the program
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Within one month after the program
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Quality of life
大体时间:Within one month after the program
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Within one month after the program
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Severity of cognitive dysfunction, as measured using FACT-Cog
大体时间:Within one month after the program
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Within one month after the program
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Severity of symptom burden, as measured using Rotterdam Symptom Checklist
大体时间:Within one month after the program
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Within one month after the program
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合作者和调查者
调查人员
- 首席研究员:Alexandre Chan, PharmD、National University of Singapore
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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