Behavioral Symptom Management Program for Breast Cancer in Singapore and The US
Feasibility and Acceptability of A Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and The US
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedNovember 6, 2018
June 1, 2017
1.1 years
July 12, 2016
November 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in symptoms of psychological distress
Psychological distress will be measured using the Hospital Anxiety Depression Scale (HADS)
Up to 6 weeks
Secondary Outcomes (2)
Pain level
Up to 6 weeks
Fatigue
Up to 6 weeks
Study Arms (2)
Cognitive behavioral therapy (CBT) group
EXPERIMENTALParticipants will receive 4 sessions that lasts approximately 50 mins. The sessions will teach patients to manage their symptoms.
Waitlist control (WLC) group
NO INTERVENTIONThe WLC group receives standard usual care before being offered the same CBT protocol and assessment thereafter.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke-NUS Graduate Medical Schoollead
- Duke Universitycollaborator
Study Sites (1)
National Cancer Centre
Singapore, 169610, Singapore
Related Publications (2)
Somers TJ, Abernethy AP, Edmond SN, Kelleher SA, Wren AA, Samsa GP, Keefe FJ. A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. J Pain Symptom Manage. 2015 Oct;50(4):553-8. doi: 10.1016/j.jpainsymman.2015.04.013. Epub 2015 May 27.
PMID: 26025279RESULTMahendran R, Lim HA, Tan JY, Chua J, Lim SE, Ang EN, Kua EH. Efficacy of a brief nurse-led pilot psychosocial intervention for newly diagnosed Asian cancer patients. Support Care Cancer. 2015 Aug;23(8):2203-6. doi: 10.1007/s00520-015-2771-0. Epub 2015 May 23.
PMID: 26001988RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Teo, PhD
Duke-NUS Graduate Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 12, 2016
First Posted
August 12, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
November 6, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share