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临床试验/NCT02865148
NCT02865148已完成不适用

Feasibility and Acceptability of A Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and The US

Duke-NUS Graduate Medical School2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016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
40
试验地点
2
主要终点
Reduction in symptoms of psychological distress

研究概览

简要总结

Research indicates that up to two-thirds of patients with advanced cancer experience significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to increase their sense of self-efficacy to manage symptoms may be helpful in alleviating multiple cancer-related symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown; however the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. The current study aims to investigate the feasibility and acceptability as well as obtain an initial estimate of efficacy of a novel, cross-cultural CBT intervention that addresses multiple symptoms in advanced breast cancer patients. The target outcomes of intervention will be reduction in symptoms of anxiety and depression, pain, and fatigue. A randomized controlled design will compare patients receiving a CBT protocol to a waitlist control in both Singapore and US patients. The larger goal of this collaborative effort is to determine the scalability of such an intervention that can potentially provide needed symptom burden relief to advanced cancer patients.

详细描述

Advanced breast cancer refers to metastatic or stage-IV breast cancer, and is associated with the highest cancer mortality and morbidity rates among women. Top symptom complaints reported by patients with advanced breast cancer include fatigue, low mood and worries, and pain. These symptoms frequently co-occur, with presence of stress hormones suggested to be a common mechanism. Greater symptoms of psychological distress (defined as anxiety and depression), pain, and fatigue is associated with decreased quality of life, and adds to the burden and suffering of patients coping with advanced breast cancer. Unfortunately these symptoms are sometimes overlooked and not adequately addressed. This is in turn is associated with increased utilization of healthcare services such as emergency department visits and frequent hospital admissions.

There is a critical need for patients with advanced breast cancer to learn strategies to self-manage common symptoms. Cognitive behavioral therapy (CBT) is a widely used,evidence-based therapy that focuses on cognitions, emotions, and behavior change. The cognitive-behavioral framework has been successfully applied in treatment of many disorders, including anxiety disorders, depression, chronic pain, and insomnia. It is posited that CBT protocols can be designed to meet the needs of advanced breast cancer patients by targeting and modifying maladaptive thoughts about the disease and treatment (e.g., irrational beliefs, unrealistic expectations) and their behavior (e.g., maladaptive coping strategies, isolation, self-negligence). These protocols are designed to teach patients strategies to increase their sense of self-efficacy to manage multiple symptoms may be helpful in alleviating psychological and physical suffering. The efficacy of CBTs for early-stage cancer has been well-documented; however the role of CBTs for late-stage cancer is less clear, particularly in a multi-symptom context. Furthermore, although CBT protocols are more widely used in the US, their use as part of oncologic care in Asia has been limited.

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
Single (Participant)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • At least 21 years old
  • Have a diagnosis of stage IV breast cancer
  • Able and willing to attend program sessions
  • Able to speak and read English

排除标准

  • Active serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records
  • Visual, hearing, or cognitive impairment that will interfere with intervention delivery
  • Unaware they have cancer

研究组 & 干预措施

Cognitive behavioral therapy (CBT) group

Experimental

Participants will receive 4 sessions that lasts approximately 50 mins. The sessions will teach patients to manage their symptoms.

干预措施: Cognitive behavioral therapy (Behavioral)

Waitlist control (WLC) group

No Intervention

The WLC group receives standard usual care before being offered the same CBT protocol and assessment thereafter.

结局指标

主要结局

Reduction in symptoms of psychological distress

时间窗: Up to 6 weeks

Psychological distress will be measured using the Hospital Anxiety Depression Scale (HADS)

次要结局

  • Fatigue(Up to 6 weeks)
  • Pain level(Up to 6 weeks)

研究者

发起方
Duke-NUS Graduate Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Teo

Assistant Professor

Duke-NUS Graduate Medical School

研究点 (2)

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