CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in decision preparedness
研究概览
简要总结
This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer
- •Currently receiving cycle three of taxane treatment
- •Approval of medical oncologist to enroll patient
- •Experiencing any CIPN based on enrollment screening question, "In the last 7 days, what was the severity of your numbness or tingling in your hands or feet at its worst? None, Mild, Moderate, Severe, Very Severe. Patient is eligible if their answer is anything except "None"
- •Access to a smartphone or similar device that can complete CIPN DecisionAid via Qualtrics while in the waiting room
排除标准
- •Inability to read or speak English
研究组 & 干预措施
Supportive care (CIPN DecisionAid)
Patients receive the CIPN DecisionAid on study.
干预措施: Informational Intervention (Other)
Supportive care (CIPN DecisionAid)
Patients receive the CIPN DecisionAid on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Change in decision preparedness
时间窗: up to 12 weeks
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
次要结局
- Change in decision preparedness(up to 12 weeks)
- Change in awareness(up to 12 weeks)
- Change in discussion confidence(up to 12 weeks)
- Change in decision empowerment(up to 12 weeks)
- Discussion satisfaction(up to 12 weeks)
- Decision satisfaction(up to 12 weeks)
- Helpfulness(up to 12 weeks)
- Taxane chemotherapy treatment decision(up to 12 weeks)