Treating Pain in Children With Cancer: Pain Buddy

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.

Because children and teens really enjoy using electronic devices, like iPods, cell phones, and computers, Pain Buddy will be downloaded onto their personal handheld electronic device (cell phone, iPad, or tablet) That way, children can carry around Pain Buddy at all times to complete daily diary entries.

The long-term goals of this research are to develop a usable, engaging electronic decision-support pain and symptom management intervention for children receiving outpatient chemotherapy using Smartphone technology and to examine the efficacy of the electronic decision-support intervention on children's pain and quality of life. These long-term goals will be accomplished through assessment of the data collected from patients, parents and physicians using the ambulatory monitoring protocol.

Primary Aim:

• Determine if Pain Buddy is more effective than an attention control in reducing pain severity among children ages 8-18 years old undergoing outpatient cancer treatment.

Secondary Aims:

• Examine the impact of Pain Buddy on symptom-related distress, health-related quality of life, functional status, and satisfaction with treatment experience.
• Determine whether baseline characteristics of children (emotional functioning) and parents (stress, attitudes regarding analgesic use for children) moderate the effect of Pain Buddy on pain severity.

Inclusion criteria

• 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).

Exclusion criteria

• 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.