Mobile Technology to Improve Pain and Symptoms in Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- Changes in pain severity, location, and affective dimensions
研究概览
简要总结
The purpose of this study is to examine the feasibility of the ambulatory monitoring protocol, called Pain Buddy, in documenting children's pain, symptoms and quality of life while receiving outpatient chemotherapy. The long term goal of Pain Buddy is to help doctors, nurses, and parents get the information they need to give children treatments for pain and symptom management that work. Using Pain Buddy, we aim to quantify the prevalence and intensity of daily pain and symptom episodes in children at home, data that will be used to develop a psychosocial intervention to be delivered electronically to children at home with a goal of improving quality of life. Secondary aims also include examining children's quality of life pre- and post- Pain Buddy and satisfaction with the use of Pain Buddy. This project has the potential to improve the quality of life of tens of thousands of children suffering from cancer each year using transformative mobile health information technology based approach to pain assessment and management.
详细描述
Approximately 12,000 children are diagnosed with cancer in the United States each year and the majority of these children will experience moderate to severe pain and disabling symptoms such as fatigue and nausea during the course of their illness. The World Health Organization (WHO) guidelines for Cancer Pain Relief and Palliative Care in Children acknowledge the large proportion of cancer patients that experience pain and the "widespread inadequacy" of pain management efforts. The overwhelming majority of children undergoing treatment for acute lymphoblastic leukemia (ALL), the most common of childhood cancers, report pain throughout the first year of treatment following diagnosis, most frequently in the legs, abdomen, head/neck, and back.1-2 Children treated with chemotherapy often experience painful conditions, including mucositis, infection, and peripheral neuropathy due to the aggressive nature of treatment protocols.3 Pediatric cancer patients also report distress due to undesirable physical and psychological symptoms such as lack of energy, insomnia and worry4-5. However, there are extremely limited controlled studies of children's cancer pain and data regarding the effectiveness of pain and symptom management strategies, particularly in the home setting.
Nonetheless, evidence suggests that cancer pain and symptoms are poorly controlled,6-9 with fewer than 30% of parents perceiving pain treatment as successful in end of life care of their child.10 Furthermore, lack of symptom alleviation leads to increased distress and poorer quality of life. Reasons for under treatment of pain and symptoms are complex and are related to deficits in the process of assessment and management of pain and symptoms in these children and lack of access to non-pharmacological interventions. 4, 11 In fact, parents and children report that despite pain, fatigue and other symptoms being a common concern, assessments for these symptoms are not performed in a systematic manner.12-13 Specifically, barriers to adequate pain management may include misunderstanding about the use of analgesia in children (i.e., fears of addiction), lack of understanding of pain expression in children, misunderstanding of the effects of opioid medication in children, and lack of education of the benefit of non-pharmacological strategies for pain management.14 Thus, despite evidence that the "vast majority of patients with cancer pain can be made comfortable,"15 tens of thousands of children with cancer suffer significant pain that is not relieved by available interventions. This is compounded by the fact that increasing numbers of children currently receive chemotherapy on an outpatient basis due to advances in healthcare and changes in the medical-economical environment. This shift in care has now placed the burden of children's pain and symptom management upon parents at home.
Unfortunately, despite the existence of symptom management guidelines, pediatric cancer pain and other symptoms that affect a child's quality of life are currently poorly controlled. Part of this problem stems from difficulties translating guidelines to actual practice. 16,17 Interventions targeting care of children in the home setting are seriously lacking, particularly psychosocial interventions. The American Pain Society (APS) guidelines for cancer pain18 include a need to recognize and treat pain promptly, involve patients in the pain management plan, continually assess and adjust the plan, and monitor processes and outcomes of pain management.6 However, traditional efforts to manage pediatric chronic conditions, such as increasing intensity of therapy and support from healthcare providers are difficult to incorporate into routine medical practice and not attractive to pediatric patients.19 Therefore, it is necessary to find innovative ways of engaging children and teens in their healthcare that are feasible to implement.
Recently there has been a national push toward involving health information technology, including electronic medical records, personal health records, and decision-support in order to minimize the gap between evidence and practice.17, 20-21 Indeed, there is preliminary empirical evidence that the use of computer-based decision-support positively impacts management of chronic pain and symptoms22 and can lead to significant improvements in clinical care, including use of appropriate treatment.22-25 For example, text messaging (TM) is a simple, efficient system and over half of teens in the U.S. have mobile phones and over a third report using TM26 and these numbers are increasing. Text messaging is beginning to be used as a modality to engage teens in their healthcare and improve health outcomes.19, 27-29 In addition, TM programs are well-received by children.19 From a translational standpoint, TM technology is easily adopted, implemented, and maintained; requires little cost; and reduces time required by staff to support pediatric healthcare management.19 Moreover, electronic means of assessment (e.g., personal digital assistants, Smartphones) have been shown to greatly increase adherence to monitoring health information data.30 Because of the limited data on the experience of pain and symptom management in children with cancer, including how symptoms are assessed by parents, how often pain medication is given, what nonpharmacological strategies are used, and factors that impact parental pain and symptom management practices, there is a pressing need for research in this population. The lack of systematic assessments in children with cancer has hindered development and testing of new and innovative pain and symptom management interventions.
Accordingly, through use of mobile technology a monitoring ambulatory protocol (electronic pain diary), called Pain Buddy, has been developed to quantify the prevalence and intensity of daily pain and symptom episodes in children with cancer as well as understand the contextual factors that impact the experience of children's cancer pain. Pain Buddy is a user interface (application) which contains a personalized avatar (Pain Buddy) to guide children and parents through daily diary entries using mobile devices. The Pain Buddy application was developed in collaboration with the California Institute for Telecommunications and Information Technology (Calit2) at UCI and has been designed to be used with children age 8-18, receiving outpatient chemotherapy, as well as their parents. Pain Buddy will capture real time pain data from patients and that will ultimately allow for remote monitoring of patient symptoms. Remote symptom monitoring in real time will provide an opportunity for implementation of appropriate interventions, thereby introducing the potential to decrease pain and symptoms and improve quality of life in children with cancer. The use of symptom monitoring and skills training will further increase patient engagement in healthcare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 8-18 years
- •Currently undergoing outpatient treatment for cancer
- •Patients who are able to speak, read, and write in English. Parents who are able to speak, read, and write in English or Spanish
- •Have home internet access to use Pain Buddy (the internet will be used to securely send the pain information to the research team).
排除标准
- •Cognitive impairment, such as a developmental delay or mental retardation that would prevent children from being able to use the Pain Buddy program.
- •Children diagnosed with acute myelogenous leukemia (AML) or acute promyelocytic leukemia (APL) as the treatment protocols for these children are largely inpatient, precluding use of the intervention.
研究组 & 干预措施
Pain Buddy
Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily diaries using Pain Buddy and will also be taught cognitive and behavioral coping skills, like deep breathing, imagery, and relaxation, to deal with pain and symptoms. The skills will be taught through the electronic tablet. Pain and symptom information, collected daily by Pain Buddy, will be sent to a health care provider on the oncology treatment team, who will contact patients when certain thresholds are reached and will instruct the patients on best ways to control pain and symptoms.
干预措施: Pain Buddy (Other)
Control
Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily pain diaries using Pain Buddy, but will not receive skills training or remote monitoring of data.
结局指标
主要结局
Changes in pain severity, location, and affective dimensions
时间窗: Baseline and day 60
Child's pain is assessed using the 3 components of the Adolescent Pediatric Pain Tool. 1. Children use a body outline/map to identify areas they are experiencing pain. 2. Children report pain intensity from "not in pain" (score of 0) and "worst pain" (score of 100) using the 100-mm Visual Analog Scale for Pain. 3. Children are presented with a pain quality word descriptor list within 4 categories (Sensory, affective, evaluative, and temporal).
Changes in Children's Anxiety and Depression assessed using the Revised Child Anxiety and Depression Scale (RCADS)
时间窗: Baseline, day 60, and day 180
Parent and Child's self report on 47-item scale with subscales including separation anxiety, social phobia, generalized anxiety, panic disorder, obsessive compulsive disorder, and major depression. Items are rated on a 4-point Likert scale from 0 ("never") to 3 ("always"). Higher scores suggest higher levels of anxiety and depression.
Changes in Perceived Stress (parent self-report)
时间窗: Baseline, day 60, and day 180
Parents are administered the 14-item Perceived Stress Scale and asked to rate statements such as "In the past month, how often have you been upset because of something that happened unexpectedly?" and "In the past month how often have you felt that things were going your way?" Subjects rate the items on a 5-point Likert-type scale with higher scores reflecting greater perceived stress.
Changes in prevalence and intensity of pain episodes and other distressing physical and psychological symptoms.
时间窗: Baseline and day 60
As part of the daily electronic Pain Buddy diary, children are administered the Memorial Symptoms Assessment Scale. Children 8-9 receive an 8-item instrument and are asked to report frequency (i.e. a very short time, a medium amount, almost all the time) severity (i.e. a little, a medium amount, very), and how distressful (i.e. not at all, a little, a medium amount, very) each symptom was. Children 10-18 receive a 30-item instrument and are asked to report how often (i.e. almost never, sometimes, a lot, almost always), how severe (i.e. slight, moderate, severe, very severe), and how distressful (i.e. not at all, a little bit, somewhat, quite a bit, very much) each symptom was.
Changes in children's quality of life since using Pain Buddy is assessed using the Pediatric Quality of Life Inventory (child self-report, ages 8-12, 13-18; parent report child ages 8-12, 13-18)
时间窗: Baseline, day 60, and day 180
Children and parents are asked to report on the child's health related quality of life. The measure incorporates a generic, cancer, and fatigue module and asks question on a 5-point likert scale from 0 ("Never") to 4 ("Almost Always") For questions like "I have trouble sleeping." Higher scores on the scale suggest a better health related quality of life. These responses are useful in understanding pain information collected in Pain Buddy.
State-Trait Anxiety Inventory (STAI) (parent self-report)
时间窗: Baseline
Only the Trait section of the questionnaire is administered to parents to assess their self reported anxiety. Items rated on a 4-point Likert Scale from 1 ("Almost Never") to 4 ("Almost Always"). Higher scores suggest higher levels of anxiety.
Medication Attitude Questionnaire (MAQ) (parent self-report)
时间窗: Baseline
Parents were asked to report their attitudes regarding use of pain medication for treating children's pain. The factors assessed were Appropriate-Use (e.g., "Giving children pain medication for pain teaches proper use of drugs"), Side-Effects (e.g., "Side effects are something to worry about when giving children pain medication"), and Avoidance (e.g., "Pain medication works best if saved for when the pain is quite bad").
Changes in Pain Severity Over Time
时间窗: Baseline and day 60
As part of the daily electronic Pain Buddy diary, children were administered the Memorial Symptoms Assessment Scale. Children 8-9 years of age received an 8-item instrument and were asked to report frequency (i.e. a very short time, a medium amount, almost all the time) severity (i.e. a little, a medium amount, very), and how distressful (i.e. not at all, a little, a medium amount, very) each symptom was. Children 10-18 years of age received a 30-item instrument and were asked to report how often (i.e. almost never, sometimes, a lot, almost always), how severe (i.e. slight, moderate, severe, very severe), and how distressful (i.e. not at all, a little bit, somewhat, quite a bit, very much) each symptom was. The items related to pain severity were used to calculate a 0-10 continuous score of self-reported pain severity for participants in each group. For this outcome, lower scores represent improvement in pain severity.
次要结局
- Medication Attitude Questionnaire (MAQ) (Parent Self-report)(Baseline (T1))
- Changes in Perceived Stress (Parent Self-report)(Baseline (T1), day 60 (T2), and day 180 (T3))
- State-Trait Anxiety Inventory (STAI) (Parent Self-report)(Baseline (T1))
- Changes in Children's Anxiety and Depression Assessed Using the Revised Child Anxiety and Depression Scale (RCADS)(Baseline (T1) , day 60 (T2) , and day 180 (T3))
- Changes in Children's Quality of Life Since Using Pain Buddy is Assessed Using the Pediatric Quality of Life Inventory (Child Self-report, Ages 8-12, 13-18; Parent Report Child Ages 8-12, 13-18)(Baseline (T1) , day 60 (T2) , and day 180 (T3))
研究者
Michelle Fortier
Study Principal Investigator
University of California, Irvine