Patient Preferences for Treatments for Hepatocellular Cancer (HCC) in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 120
- 主要终点
- Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC
研究概览
简要总结
This non-interventional cross-sectional online survey will evaluate preferences among patients with self-reported HCC. The survey will ask patients to express their preferences regarding descriptions of HCC treatments, which will include sorafenib (which will be described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that patients may have received before completing this online survey were given regardless of their participation in this survey. Questions also include asking patients to rank various treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative to each other. The ultimate goal is to better understand patient perceptions of these treatments and to provide evidence to help in patients' and physicians' treatment decision-making in HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following eligibility criteria will be used:
- •Have a diagnosis of HCC
- •Are > 20 years of age
- •Reside in Japan
- •Are able to read and understand Japanese to provide informed consent and complete the survey instrument
排除标准
- •None are currently considered
研究组 & 干预措施
HCC patients / Cohort 1
Patient preferences associated with oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC and their perceptions regarding the respective treatment characteristics
干预措施: Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)] (Drug)
结局指标
主要结局
Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC
时间窗: up to 8 weeks
Best-Worst Scaling scores for each attribute: 1. Prevents formation of new blood vessels 2. 2 tablets twice a day 3. Risk of hand-foot skin reaction 4. Risk of diarrhea 5. Risk of stopping treatment because of side effects 6. Artery branches in liver are plugged 7. Several hour medical procedure under sedation with hospitalization 8. Medical procedure repeated when needed 9. Risk of liver damage 10. Ongoing chemotherapy drugs to the liver 11. Container and a catheter implanted in the body 12. Risk of fever, abdominal pain, and nausea 13. Risk of complications with catheter
次要结局
- Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC(up to 8 weeks)
- Like/dislike ratings of each treatment attribute (Extent of patients like or dislike of different treatment attributes)(up to 8 weeks)
- Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC(up to 8 weeks)
- Maximum acceptable risk of hand-foot skin reaction willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time(up to 8 weeks)
- Maximum acceptable risk of life-threatening side effect willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time(up to 8 weeks)