ICAN Symptoms Duke-NUS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioral Mutli-Symptom management(CBT)<br>Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions. | Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)<br>* Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.<br>|
| No Intervention: Treatment as usual<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by study accrual by meeting recruitment goal | Feasibility will be shown by meeting targeted study accrual (N=40) in the 12-month study period. | 6 weeks | 
| Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment. | Feasibility will be shown by no more than 20% study attrition. | 6 weeks | 
| Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant | Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4) | 6 weeks | 
| Acceptability, as measured by Client Satisfaction Questionnaire 10-item version | Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ | 6 weeks | 
| Cultural Sensitivity | Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety and depression | The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms) | Baseline and 6 weeks | 
| Change in pain | Pain will be assessed with the Brief Pain Inventory (BPI) | Baseline and 6 weeks | 
| Change in fatigue | Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form. | Baseline and 6 weeks | 
| Change in Pain | Pain will be assessed with the Pain Disability Index | Baseline and 6 weeks |