ICAN Symptoms Duke-NUS



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:10/17/2018
Start Date:November 2016
End Date:August 2018

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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.

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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Tamara J Somers, PhD
Phone: 919-416-3408
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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