ICAN Symptoms Duke-NUS

Duke University

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02787993

Pro00072023

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.