The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- Child Distress - unrelieved symptoms
研究概览
简要总结
Over 50% of children dying from cancer still suffer from symptoms that could be effectively alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) Study was to evaluate whether providing feedback to families and providers about how the child is feeling improved child distress and quality of life (QoL) in children with advanced cancer.
PediQUEST is a computerized survey that asks the child and/or parents how the child has been feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other aspects of life, such as school and friends, are going. After the survey is complete a report that summarizes patient/parent answers is printed. When a child reports moderate to high distress from any symptom an email is automatically sent to the primary providers (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care services) alerting them about the child's distress.
In this study we evaluated whether using PediQUEST and providing printed reports to parents and providers reduced distress and improved quality of life in children with advanced cancer. In addition, we wanted to understand whether it was feasible to carry out a randomized controlled trial in children with advanced cancer. Finally, the data collected, will be used to describe the natural history of symptoms and quality of life as reported by the children.
Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey at most once a week. A random half of the children received the feedback intervention, i.e. patients, parents, and providers received printed reports (and emails if the child was in distress). The other half only completed the PediQUEST surveys and did not receive reports. We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST reports had any effect on child distress and quality of life.
详细描述
Introduction: Cancer is the leading cause of nonaccidental death in childhood.(Arias et al. 2003) In spite of significant scientific progress, one quarter of children with cancer still do not survive(Greenlee et al. 2000), and over 50% experience substantial suffering that could be alleviated.(Wolfe et al. 2000a) Pediatric palliative care is now an expected standard of care and research in this field has been established as a national priority by the Institute of Medicine (IOM).(Field et al. 2003) Earlier work by our group suggested that when parents and physicians recognized at an early stage that a child had no realistic chance of cure, they were more likely to integrate elements of effective palliation into the child's care. However, this early stage concordance about prognosis was rare.(Wolfe et al. 2000b) Communication and delivery of optimal care in the advanced stages of illness is especially challenging in children.(Shelton 1999) The anticipation of losing a child and physicians' own difficulties(Saunders 1979-80; Hilden et al. 2001) may hinder discussions about poor prognosis and impact on decision-making and integration of palliative care. Thus attention to symptom management and quality of life (QoL) in children with advanced cancer may be limited.
The collection of standardized symptom and QoL data has shown to enhance physician's recognition, knowledge and accuracy in the assessment and palliation of symptoms, and to increase patient-provider discussions about QoL issues and directly improve patient's QoL.(Detmar et al. 2002; Taenzer et al. 2000; Velikova et al. 2004) Whether these findings are applicable to children remains to be established.
One of the obstacles to routine symptom and QoL assessment in children is the need of developmentally adapted(Eiser et al. 2001b; Eiser et al. 2001c; Hain 1997) and parent-proxy tools(Eiser et al. 2001a), making the paper and pencil format extremely impractical. Computerized surveys offered a potential solution. Patient acceptance of such devices has been found to be high.(Buxton et al. 1998; Velikova et al. 2002; Velikova et al. 1999; Velikova et al. 2001) Our current project -the PediQUEST Study- consists of a pilot for a randomized controlled trial (RCT) aimed at assessing the effect of routinely reporting symptom and QoL data. We will use an innovative data collection strategy: a hand-held computer devise, the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) that readily administers a user-appropriate survey instrument and generates reports summarizing how the patient feels.
As far as we are aware of, this will be the first RCT conducted in children with advanced cancer to evaluate a palliative care intervention. Given the challenges with doing research in this population, we propose to simultaneously focus on several goals.
Aims: Aim 1: (Feasibility study) Assess the feasibility of conducting a randomized controlled supportive care trial (RCT) in children with advanced cancer. Aim 2: (PediQUEST Evaluation) Preliminarily assess the effect of routinely feeding back QoL and symptom data to families and primary oncologists, and alerting supportive care teams about highly distressing symptoms. Aim 3: (Descriptive study) Prospectively explore determinants of child's suffering and parental-physician discordance regarding prognosis and treatment goals in children with advanced cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children >=2-years old with at least a 2-week history of progressive, recurrent, or non-responsive cancer of any type or decision not to pursue cancer directed therapy.
- •Child's parent must have spoken and written command of English or Spanish.
- •Child's parent must have the ability to understand and complete self-administered surveys.
排除标准
- •Patients who have an isolated relapsed solid tumor treated with surgery or radiation alone.
- •Patients with hematological malignancies who have achieved remission after the first induction attempt, whose treatment plan includes their first Stem Cell Transplant (SCT), and have an identified donor (must meet all 3 criteria to be excluded).
- •Patients who are not regular patients at one of the two participating institutions.
- •Foster parents who do not have legal guardianship.
结局指标
主要结局
Child Distress - unrelieved symptoms
时间窗: 20 weeks
Child distress-unrelieved symptoms will be assessed through the proportion of patients with unrelieved symptoms (any symptom/s reported as causing moderate to high distress or FPS-R score \>=8 in 2 consecutive PediQUEST evaluations)
Trends of PedsQL Total Scores
时间窗: 20 weeks
Trends of PedsQL total scores over time. PedsQL is a continuous variable (Range: 0-100. 100 highest quality of life).
Trends of MSAS total scores
时间窗: 20 weeks
Trends of MSAS total score over time(MSAS total score is a continuous variable; range: 0-100. 100 worst).
Trends of MSAS physical scores
时间窗: 20 weeks
Trends over time of MSAS physical subscale scores (MSAS physical subscale score is a continuous variable. Range: 0-100. 100 highly symptomatic.)
Trends of MSAS psychological scores
时间窗: 20 weeks
Trends over time of MSAS psychological subscale scores (MSAS psychological subscale scores is a continuous variable. Range: 0-100. 100 highly symptomatic.)
Trends of PedsQL Physical Subscale Scores
时间窗: 20 weeks
Trends of PedsQL physical subscale scores over time. PedsQL physical score is a continuous variable (Range: 0-100. 100 highest quality of life).
Trends of PedsQL Emotional Subscale Scores
时间窗: 20 weeks
Trends of PedsQL emotional subscale scores over time. PedsQL emotional score is a continuous variable (Range: 0-100. 100 highest quality of life).
次要结局
- Parental distress over time(20 weeks)
- Patterns of care - Referrals to support services(20 weeks)
- Patterns of care - Chemotherapy during last month of life(20 weeks)
- Patterns of care - Use of hospice/home care(20 weeks)
- Patterns of care - Time of documentation of prognosis discussions(20 weeks)
- Patterns of care - Time of documentation of resuscitation status(20 weeks)
- Patterns of care - Ventilatory assistance in last day of life(20 weeks)
- Patterns of care - Hospital deaths(20 weeks)
研究者
Joanne Wolfe, MD
Principal Investigator
Dana-Farber Cancer Institute