The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Positive score on depression, anxiety, pain and fatigue measures.
研究概览
简要总结
Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indicate the causes and levels of distress they feel. However, little work has been done on how to assess distress in pediatric patients. This study will investigate the effectiveness of the Distress Thermometer as a tool to accurately measure distress in pediatric patients, and determine whether primary caregivers and physicians can also use the Distress Thermometer to accurately gauge a patient s levels and sources of distress. The study will also investigate the effectiveness of the Distress Thermometer compared with other means of measuring fatigue, mood, and pain levels.
This study will include approximately 90 patients between 7 and 21 years of age who are currently enrolled in a National Institutes of Health pediatric research study. It will also include responses from the primary caregivers and primary medical providers of the patients involved in the study.
All patients will complete the Distress Thermometer s self-reported distress scale and other standardized measures of anxiety, depression, fatigue, and pain. In addition, patients between 18 and 21 years of age will be asked to assess the benefits and negative effects of participating in psychosocial research.
On the same day, the patient s primary caregiver and primary medical provider will complete a Distress Thermometer survey to estimate the patient s distress level. If either the patient or the primary caregiver indicate high levels of distress or mood symptoms, the researchers will offer them an opportunity to speak with a mental health professional. The primary medical provider will also receive a copy of the responses reported on the patient s Distress Thermometer.
详细描述
OBJECTIVE:
The purpose of this protocol is to evaluate a measure that would assist clinicians in assessing the presence of psychological distress in children and adolescents with serious medical illnesses.
Aim 1: To assess the inter-rater reliability of the Distress Thermometer by comparing ratings of the patient s distress given by the patient, the primary caregiver and the patient s primary medical provider.
Aim 2: To assess the concurrent validity (i.e. the extent to which a test correlates with other previously validated measures of similar constructs) of the Distress Thermometer, a brief screening tool for psychological distress, as compared to validated measures of psychological symptoms (i.e. depression, anxiety, pain and fatigue) in patients with pediatric cancer, Neurofibromatosis Type 1 (NF1) HIV-1 infection, Primary Immune Deficiencies (PIDs), DNA repair diseases, sickle cell disease, and Li-Fraumeni.
Aim 3: To assess the acceptability of completing the Distress Thermometer to patients, primary caregivers, and medical providers.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Positive score on depression, anxiety, pain and fatigue measures.
次要结局
未报告次要终点
