MedTrace Logo

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

NCT02865148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-06

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    lead OTHER

Principal Investigators

  • Irene Teo, PhD · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865148 on ClinicalTrials.gov