Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy of the ePRO monitoring instrument for infection-related symptoms
研究概览
简要总结
The goal of this observational study is to improve the treatment of hematological patients with secondary immunodeficiency (SID) by developing a patient-reported outcome (PRO) instrument to detect clinically diagnosed infections. The study focuses on adults diagnosed with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who are at increased risk of infections due to SID.
The main questions it aims to answer are:
- Can a newly developed PRO screening tool for infection-related symptoms reliably detect infections in patients with SID?
- How does the health-related quality of life change over the treatment course
Participants will:
- Complete daily electronic PRO questionnaires (ePRO) to monitor infection-related symptoms
- Complete ePRO health-related quality of life questionnaires every 1.5 months
- Participate in study visits every three months to ensure documentation of clinical data
详细描述
The aim of this observational study is to develop an ePRO symptom monitoring tool to identify infections among patients with MM or CLL who recently started an anticancer therapy.
This multicenter trial, conducted in participating sites in Germany in Austria, targets a total of 120 adult patients to complete daily ePRO questions in a mobile app regarding current infection-related symptoms.
Objectives:
Primary:
To develop and evaluate the diagnostic accuracy of a newly developed PRO screening measure for detecting clinically diagnosed infections in hematological patients with SID.
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 patient (>=18 years of age)
- •Access to an internet device (e.g., personal computer or tablet to use a web-based platform, or smartphone where the study app can be installed - all common iOS and Android systems)
- •German-speaking
- •Diagnosis of multiple myeloma or chronic lymphocytic leukemia
- •Secondary immunodeficiency (defined as: recurrent infections, infections requiring inpatient treatment, hypogammaglobulinemia, neutropenia and/or lymphopenia on differential blood cell counts, deficit in lymphocyte subsets as assessed by flow cytometry)
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of the ePRO monitoring instrument for infection-related symptoms
时间窗: From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first
Evaluation of diagnostic accuracy of the daily ePRO screening measure to detect infections as diagnosed by a clinician (CTCAE).
次要结局
- Changes in health-related quality of life measured with the EORTC QLQ-MY20(From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first)
- Changes in health-related quality of life measured with the EORTC QLQ-C30(From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first)
- 2. Changes in health-related quality of life measured with the EORTC QLQ-CLL17(From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first)