ICAN Symptoms Duke-NUS
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)
- Registration Number
- NCT02787993
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Mutli-Symptom management(CBT) Cognitive Behavioral Mult-Symptom management(CBT) Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
- Primary Outcome Measures
Name Time Method Cultural Sensitivity 6 weeks Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity.
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant 6 weeks Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
Feasibility as measured by study accrual by meeting recruitment goal 6 weeks Feasibility will be shown by meeting targeted study accrual (N=40) in the 12-month study period.
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment. 6 weeks Feasibility will be shown by no more than 20% study attrition.
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version 6 weeks Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
- Secondary Outcome Measures
Name Time Method Change in fatigue Baseline and 6 weeks Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Change in Pain Baseline and 6 weeks Pain will be assessed with the Pain Disability Index
Change in pain Baseline and 6 weeks Pain will be assessed with the Brief Pain Inventory (BPI)
Change in anxiety and depression Baseline and 6 weeks The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms)
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States