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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Severity of anxiety, as measured using Beck Anxiety Inventory
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
研究组 & 干预措施
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.
干预措施: Psychoeducation group (Behavioral)
Usual Care
No active intervention provided.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Severity of anxiety, as measured using Beck Anxiety Inventory
时间窗: Within one month after the program
Quality of life
时间窗: Within one month after the program
次要结局
- Severity of cognitive dysfunction, as measured using FACT-Cog(Within one month after the program)
- Severity of symptom burden, as measured using Rotterdam Symptom Checklist(Within one month after the program)
研究者
Alexandre Chan
Associate Professor
National University of Singapore