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Behavioral Symptom Management Program for Breast Cancer in Singapore and The US

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 21 years old
  2. Have a diagnosis of stage IV breast cancer
  3. Able and willing to attend program sessions
  4. Able to speak and read English

Exclusion Criteria:

  1. Active serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records
  2. Visual, hearing, or cognitive impairment that will interfere with intervention delivery
  3. Unaware they have cancer

Sites / Locations

  • National Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive behavioral therapy (CBT) group

Waitlist control (WLC) group

Arm Description

Participants will receive 4 sessions that lasts approximately 50 mins. The sessions will teach patients to manage their symptoms.

The WLC group receives standard usual care before being offered the same CBT protocol and assessment thereafter.

Outcomes

Primary Outcome Measures

Reduction in symptoms of psychological distress
Psychological distress will be measured using the Hospital Anxiety Depression Scale (HADS)

Secondary Outcome Measures

Pain level
Pain will be measured using the Brief Pain Inventory (BPI)
Fatigue
Fatigue will be measured using the PROMIS Fatigue scale

Full Information

First Posted
July 12, 2016
Last Updated
November 2, 2018
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02865148
Brief Title
Behavioral Symptom Management Program for Breast Cancer in Singapore and The US
Official Title
Feasibility and Acceptability of A Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and The US
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy (CBT) group
Arm Type
Experimental
Arm Description
Participants will receive 4 sessions that lasts approximately 50 mins. The sessions will teach patients to manage their symptoms.
Arm Title
Waitlist control (WLC) group
Arm Type
No Intervention
Arm Description
The WLC group receives standard usual care before being offered the same CBT protocol and assessment thereafter.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in symptoms of psychological distress
Description
Psychological distress will be measured using the Hospital Anxiety Depression Scale (HADS)
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Pain level
Description
Pain will be measured using the Brief Pain Inventory (BPI)
Time Frame
Up to 6 weeks
Title
Fatigue
Description
Fatigue will be measured using the PROMIS Fatigue scale
Time Frame
Up to 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Teo, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26025279
Citation
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.
Results Reference
result
PubMed Identifier
26001988
Citation
Mahendran 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.
Results Reference
result

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Behavioral Symptom Management Program for Breast Cancer in Singapore and The US

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