Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 21
- 主要终点
- To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.
研究概览
简要总结
This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.
详细描述
The PROSPER study aims to collect information about the experiences of patients with MF/SS receiving Poteligeo and of their caregivers in real-world clinical practice. The objective of this study is to generate patient-level data to provide insights into real world clinical practice and an understanding of treatment decisions, as well as to collect patient reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience and burden, to demonstrate the full impact of treatment and the relevant patient experience in real-world clinical practice. The study will be conducted 6 countries, including North America, United Arab Emirates and countries in Europe, at 19 sites known to treat and follow-up patients with MF/SS. Patients will be followed for up to 50 weeks from study enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient aged ≥18 years
- •Confirmed diagnosis of MF/SS
- •Disease staging at enrollment has been completed
- •About to commence primary treatment with Poteligeo® as per reimbursed indication
- •Patient is willing and able to complete the symptom diary and PROs.
- •Patient is willing and able to provide written informed consent to participate in the study in a manner approved by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) and local regulations
排除标准
- •Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records
- •Patient currently participating in an interventional clinical trial
研究组 & 干预措施
Patients with MF/SS
Adult patients with diagnosed MF/SS receiving Poteligeo treatment.
干预措施: Poteligeo (Drug)
结局指标
主要结局
To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.
时间窗: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
Patients will complete PRO questionnaire BFI to assess changes in fatigue
To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.
时间窗: Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation.
Patients will complete a symptom diary at regular intervals throughout the study to record symptoms including skin pain, skin itch, skin flaking, skin redness, difficulty regulating body temperature and sleep problems.
To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo.
时间窗: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
Patients will complete PRO questionnaire CTCL-QoL at regular time points throughout the study to assess any changes in quality of life.
To assess change in the HRQoL of the patient's main caregiver
时间窗: First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation.
The patient's main caregiver will be invited to complete the CareGiver Oncology Quality of Life questionnaire (CarGOQoL)
次要结局
未报告次要终点