Behavioral Symptom Management Program for Breast Cancer in Singapore and The US
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Behavioral Symptoms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): CBT-based protocol tailored to advanced breast cancer patients with a focus on managing a broad array of symptoms including psychological distress, pain, and fatigue. Important features of the protocol are: 1) a unique motivational interviewing component in the first session that will focus on patients' motivation for engaging in the protocol, confidence (i.e., self-efficacy) to learn new strategies, and potential barriers to adopting recommendations for lifestyle change; and 2) protocol that targets multiple symptoms, and 3) adapted to meet the unique needs of advanced breast cancer patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care