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

NCT ID: NCT02865148

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Cognitive behavioral therapy (CBT) group

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

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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.

Waitlist control (WLC) group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioral therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: lead

Responsible Party

Irene Teo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Teo, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke-NUS Graduate Medical School

Locations

National Cancer Centre

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: RESULT

PMID: 26025279 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26001988 (View on PubMed)

Other Identifiers

DukeNUS

Identifier Type: -

Identifier Source: org_study_id