Clinical trial NCT02787993: ICAN Symptoms Duke-NUS
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as measured by study accrual by meeting recruitment goal
timeFrame: 6 weeks
measure: Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
timeFrame: 6 weeks
measure: Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
timeFrame: 6 weeks
measure: Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
timeFrame: 6 weeks
measure: Cultural Sensitivity
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in anxiety and depression
timeFrame: Baseline and 6 weeks
measure: Change in pain
timeFrame: Baseline and 6 weeks
measure: Change in fatigue
timeFrame: Baseline and 6 weeks
measure: Change in Pain
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: