Indolent Lymphoma: Is "Watch and Wait" Really "Worry and Wait"? A Patient-Reported Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
研究概览
简要总结
Indolent lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, low-grade follicular lymphoma, and Waldenström macroglobulinemia, are slow-growing cancers often managed initially with a watchful waiting strategy. This approach avoids unnecessary side effects of early therapy but may negatively impact patients' quality of life (QoL) due to anxiety, uncertainty, and self-monitoring of symptoms. Previous research has suggested increased distress and greater QoL decline in patients under observation compared to those receiving treatment, despite similar or lower disease burden. Moreover, poor QoL has been shown to independently predict overall survival in non-Hodgkin lymphoma patients. However, there are limited data from Asian populations, where cultural factors, health insurance systems, and treatment access differ significantly. This study will evaluate the impact of watchful waiting on patient-reported QoL among Korean patients with indolent lymphoma, providing evidence specific to this population and healthcare setting.
详细描述
This is an observational, patient-reported outcomes study of indolent lymphoma patients managed with a watch-and-wait strategy. Eligible participants include adults (≥19 years) diagnosed at Seoul National University Hospital with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL), according to WHO criteria. Patients must be recently diagnosed, currently under observation, and able to understand and complete the survey independently. Patients receiving active systemic therapy or with cognitive impairment precluding self-report are excluded.
The target enrollment is up to 150 participants, estimated based on the number of eligible outpatients seen over a 3-month period. Recruitment will occur during outpatient visits, where physicians will introduce the study. After providing written informed consent, patients will complete validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules such as QLQ-CLL17 or QLQ-NHL) to assess quality of life, distress, and emotional well-being. Clinical and demographic data (e.g., age, sex, diagnosis, stage, ECOG, marital status, outpatient interval) will also be collected from medical records. Surveys are expected to take at least 20 minutes and will be completed by patients during outpatient waiting periods.
The study involves no therapeutic intervention and poses no risks beyond minimal psychological burden comparable to daily life or routine clinical assessments. Data will be analyzed descriptively and statistically to evaluate the impact of observation on quality of life and psychosocial outcomes. Unlike prior studies, this investigation will focus on Korean patients, reflecting Asian cultural context, local health insurance structure, and treatment accessibility, thereby providing novel and clinically meaningful insights.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥19 years old.
- •Diagnosed with indolent lymphoma (CLL/SLL, MZL, FL, or WM/LPL) at Seoul National University Hospital according to WHO criteria.
- •Currently managed with watch-and-wait (no active systemic therapy).
- •Able to understand and independently complete the study questionnaires.
- •Provide voluntary informed consent.
排除标准
- •Receiving active systemic anti-lymphoma therapy at the time of enrollment.
- •Cognitive impairment or other condition preventing independent completion of the questionnaire.
结局指标
主要结局
Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
时间窗: At enrollment during a routine outpatient visit for patients managed with watch-and-wait; single assessment completed once on the day of enrollment (expected 20-30 minutes).
Patient-reported quality of life will be measured using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which includes global health status/QoL, functional scales, and symptom items. Scores will be transformed to a 0-100 scale according to the official EORTC scoring manual; higher functional and global health scores indicate better quality of life, whereas higher symptom scores indicate worse symptoms.
次要结局
未报告次要终点
研究者
JaMin Byun
Professor of Hematology/Oncology
Seoul National University Hospital