AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 主要终点
- Quality of Life as measured by the FACT-BMT score
研究概览
简要总结
Survivors of allo HCT can experience long-term survival, which is however limited by a number of late effects. These will be addressed in AlloLife to improve quality of life (QoL) and survival.
详细描述
The complex intervention in AlloLife will consist of a set of technically-supported tools that will enable active care management through the patient and treating physician to improve QoL.
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
- Single (Participant)
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
- •Age > 18
- •Patients with performed allogeneic stem cell transplantation any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen and at least at day +20 after HCT.
- •Hematologic Remission after HCT at study entrance, MRD positive patients are allowed to enter the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship to participate in the study
- •Access to an internet connected device (smartphone/tablet/computer)
- •Able to understand and communicate in the respective language
- •Consent to use a wearable device through the time of the study
- •Consent to use a chatbot application for both healthcare data exchange and psychologic intervention
排除标准
- •Missing consent to use a wearable device and contribute personal data collected at the point of life to the study
- •ECOG performance status of 4
- •Relapse of the disease at study inclusion
- •Uncontrolled systemic infection
- •Diagnosis of a secondary malignancy requiring systemic therapy
- •Reported ongoing severe depression or potential suicidal ideation
- •Vulnerable patients such as: minor, persons deprived of liberty, persons in Intensive Care Unit unable to provided informed consent prior to the intervention
- •Other ongoing interventional protocol that might interfere with the current study primary endpoint
结局指标
主要结局
Quality of Life as measured by the FACT-BMT score
时间窗: 12 months
Change in QoL measured by the FACT BMT score on a continuous scale. The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as initially developed by McQuellon RP et al. BMT 1997. It scales between 0 (zero) and 196 on a continuous scale, where higher values refer to higher Quality of Life.
次要结局
未报告次要终点