ICAN Symptoms Duke-NUS

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

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and the US.

Up to two-thirds of women with advanced breast cancer experience significant symptom burden (e.g., distress, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to improve their symptom management may be helpful in alleviating multiple symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown in Western countries; however, the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. This study aims to investigate the feasibility and acceptability and obtain estimates of efficacy of a novel, cross-cultural multi-symptom (i.e., anxiety and depression, pain, fatigue) CBT protocol in advanced breast cancer patients. A randomized controlled design will compare patients receiving the CBT protocol to a waitlist control condition in both Singapore and United States patients. The goal of this collaborative effort is to determine the scalability of the cross- cultural intervention. This IRB protocol only represents the Duke US portion of the project; Duke-NUS will obtain their own IRB approvals.

Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.

Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.

Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.

Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant

Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ

Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity.

The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms)

Inclusion Criteria: being at least 21 years of age a diagnosis of stage IV breast cancer being able and willing to attend study appointments being able to speak/read English estimated survival of at least 3 months. Exclusion Criteria: they have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records if visual, hearing, or cognitive impairment will interfere with intervention.