Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cultural Sensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cognitive Behavioral Mutli-Symptom management(CBT)
Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
干预措施: Cognitive Behavioral Mult-Symptom management(CBT) (Behavioral)
Treatment as usual
Treatment as usual
结局指标
主要结局
Cultural Sensitivity
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 6 weeks
Feasibility will be shown by no more than 20% study attrition.
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
时间窗: 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
次要结局
- Change in fatigue(Baseline and 6 weeks)
- Change in Pain(Baseline and 6 weeks)
- Change in pain(Baseline and 6 weeks)
- Change in anxiety and depression(Baseline and 6 weeks)