Digital Support for Multiple Myeloma Quality of Life (DigiMyQoL)
Digital Support for Enhancing the Quality of Life of Patients With Multiple Myeloma: An Observational, Randomized, Prospective Study (DigiMyQoL)
The objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform.
Specifically, the study will compare Patient-Reported Outcomes (PROs) and the associated improvement in side effects and quality of life achieved through appropriate personalized educational and supportive content.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Athens、希腊、11528
- 招聘中
- Alexandra General Hospital
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接触：
- Professor Evangelos Terpos
- 电话号码：+302132162846
- 邮箱：eterpos@med.uoa.gr
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
- Patients that are able to use the digital platform/application
Exclusion Criteria:
- Patients that are not able to use the digital platform/application
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm 1 - Experimental
Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). Additionally, they receive short textual personalized educational and supportive material online. Their standard clinical treatment and monitoring continue unaffected. |
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
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无干预：Arm 2 - Control
Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). They only receive an acknowledgement of their submission. Their standard clinical treatment and monitoring continue unaffected. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Reported Outcomes (PROs)
大体时间：From enrollment, until study completion, average 1 year.
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Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study. 17 side-effects will be captured (each measured as either present or absent) throughout the study:
Only data from patients who report at least 2 times will be eligible for outcome analysis. The following calculation and evaluation will be conducted: For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 50% of the specific side-effects they had reported at previous side-effect data collection timepoints. |
From enrollment, until study completion, average 1 year.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-Free Survival
大体时间：At 12 months from each patient's enrollment
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Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry
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At 12 months from each patient's enrollment
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Overall Survival
大体时间：At 12 months from each patient's enrollment
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Overall survival: Time to death, measured from study entry
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At 12 months from each patient's enrollment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.