An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Are Satisfied With Their Overall Symptom Control
研究概览
简要总结
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
详细描述
This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, ≥18 years of age at the time of informed consent
- •A new, valid prescription for XERMELO
- •Initiating XERMELO for the treatment of carcinoid syndrome
- •Able and willing to provide informed consent prior to participation in the study
排除标准
- •Unable to understand and read English
- •Unable to access the internet
- •Prior exposure to XERMELO
研究组 & 干预措施
Carcinoid Syndrome patients initiating Xermelo
Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.
干预措施: Xermelo (Drug)
结局指标
主要结局
Percentage of Patients Who Are Satisfied With Their Overall Symptom Control
时间窗: Baseline to 6 months
The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed.
次要结局
- Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC)(Baseline to 6 months)
- Number of Patients Reporting Reduction in Rescue SSA Use(Baseline to 6 months)
- Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection(Baseline to 6 months)
- Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection(Baseline to 6 months)
- Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control(Baseline to 6 months)
- Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control(Baseline to 6 months)
- Percentage Change of Patients Who Had Reduction in Work-related Absenteeism, Presenteeism, Activity Impairment, and Overall Productivity Loss From Baseline to 6 Months After Initiating Telotristat Ethyl Based on WPAI-SHP(Baseline to 6 months)
- Percentage of Patients Reporting Weight Gain(Baseline to 6 months)