Advanced Cancer Stage and Healthcare Coverage Predict Longitudinal Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course
研究概览
简要总结
The goal of this observational study is to understand the emotional and physical burden (distress) experienced by cancer patients as they go through radiotherapy treatmen. Researchers want to learn what specific problems such as physical symptoms, financial worries, or travel issues most affect a patient's well-being and how those feelings change over the course of several weeks of care.
The main questions it aims to answer are:
Does high distress lead to negative clinical results, such as missing radiation appointments, significant weight changes, or needing to be admitted to the hospital unexpectedly? Which groups of patients are at the highest risk for severe distress (for example, those with advanced-stage cancer or those using specific types of health insurance)? What are the most common physical, practical, and emotional problems that cause distress during the different phases of treatment?
Participants will:
Complete a survey about their health history and background before treatment begins.
Rate their distress level on a scale of 0 to 10 (using a tool called a Distress Thermometer) and check off specific concerns from a 42-item list each week during their 2 to 8 weeks of radiotherapy.
Complete one final follow-up assessment one month after finishing their radiotherapy treatment.
详细描述
Study Rationale and Objective: Psychological distress in cancer patients is a recognized catalyst for negative clinical outcomes, yet it remains under-monitored in many tertiary care settings. This research was designed as a prospective longitudinal study to move beyond single-point prevalence surveys and capture the fluctuating nature of distress throughout the radiotherapy (RT) trajectory. The primary objective was to evaluate the longitudinal patterns of distress and identify independent clinical and socioeconomic predictors that correlate with treatment adherence and unplanned healthcare utilization.
Operational Framework: The study tracked a purposive sample of 374 cancer outpatients across eight distinct assessment phases: Baseline (T0): Pre-treatment assessment of demographic, socioeconomic, and clinical status.
Weekly Monitoring (T1-T8): Real-time tracking of distress levels and symptom accumulation throughout the typical 2- to 8-week RT course.
Follow-up (T9): Post-treatment assessment one month after the completion of radiotherapy.
Multidimensional Assessment: Distress was quantified using the NCCN Distress Thermometer (DT), a 0-10 visual analogue scale, with a score≥4 triggering clinical concern. To identify the specific drivers of this distress, participants utilized a 42-item Problem List covering five critical domains:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients diagnosed with cancer who are receiving treatment through radiotherapy.
- •Individuals aged 18 years or older.
- •Ability to communicate effectively and understand the Thai language.
- •Voluntary agreement to participate in the research project.
排除标准
- •Presence of emergency medical conditions or a clinical necessity to receive treatment by other methods.
- •Inability to attend follow-up monitoring assessments as dictated by the study protocol.
- •Participants who request to withdraw from the project during the study period.
- •Failure to complete the full course of radiotherapy treatment due to disease progression.
- •A physician's diagnosis of a brain or neurological condition that interferes with the patient's ability to perceive or assess their own symptoms.
研究组 & 干预措施
Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy
This arm consists of a single purposive cohort of 374 cancer outpatients who are observed across eight distinct phases: a pre-treatment baseline (T0), weekly assessments during the 2-to-8-week radiotherapy course, and a one-month post-treatment follow-up (T2). The focus of this arm is the naturalistic observation of fluctuating psychological distress levels and their correlation with clinical outcomes such as treatment adherence and unplanned hospitalizations.
干预措施: Systematic monitoring (Other)
结局指标
主要结局
Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course
时间窗: Participants are assessed at eight distinct time points: Baseline (T0): Prior to the initiation of radiotherapy. Weekly Monitoring (T1-Tn): Once per week throughout the 2-to-8-week Follow-up (T2): One month after completion
The global psychological burden is quantified using the NCCN Distress Thermometer (DT), a single-item visual analog scale ranging from 0 (no distress) to 10 (extreme distress). A score of ≥ 4 is established as the clinical cut-off point, indicating moderate-to-severe distress that warrants multidisciplinary intervention.
次要结局
- Identification of independent predictors of moderate-to-severe psychological distress(Analysis is conducted using data collected from the pre-treatment baseline (T0) through the completion of the 2-to-8-week radiotherapy course and the one-month post-treatment follow-up (T2))
研究者
Saengrawee Thanthong
Dr.
Chulabhorn Cancer Center