Treating Pain in Children With Cancer: Pain Buddy
Mobile Technology to Improve Pain and Symptoms in Children With Cancer
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California, Irvine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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 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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Pain Severity Over Time
Time Frame: 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.
|
Baseline and day 60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Attitude Questionnaire (MAQ) (Parent Self-report)
Time Frame: Baseline (T1)
|
Medication Attitude Questionnaire (MAQ) (parent self-report). This questionnaire was developed to examine attitudes about using pain medication for treating children's pain. The instrument consists of 16 items each rated on a seven-point Likert-type scale that ranges from strongly disagree to strongly agree. The factors were Appropriate-Use, 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"). Scores for the side effects scale range from 5-35. Scores for Avoidance range from 7-49. Scores for Appropriate Use range from 4-28 A total score reflective of misconceptions is calculated by summing all the subscales. The total score ranges from 16-112 with higher scores indicating more negative attitudes towards use of pain medication. |
Baseline (T1)
|
|
Changes in Perceived Stress (Parent Self-report)
Time Frame: Baseline (T1), day 60 (T2), and day 180 (T3)
|
Perceived Stress Scale (PSS) (parent self-report) The PSS is a widely used 14-item self-report measure of perceived stress.
Parents will be 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.
Seven items are reverse-keyed and items are summed to obtain the final score.
Total scores range from 0-56.
Higher scores reflect greater perceived stress.
The PSS has been shown to have adequate reliability and validity.
Completed at baseline, 60 days, and 6 month follow-up using REDCap
|
Baseline (T1), day 60 (T2), and day 180 (T3)
|
|
State-Trait Anxiety Inventory (STAI) (Parent Self-report)
Time Frame: Baseline (T1)
|
State-Trait Anxiety Inventory (STAI) (parent self-report).
This is a widely used self-report anxiety assessment instrument for adults.The questionnaire contains two separate, 20-item, 4-point self-report rating scales for measuring trait and state anxiety.
TOTAL scores are summed for situational and trait anxiety.
Scores range from 20 to 80 each; higher scores denote higher levels of anxiety.
For our purposes, only the one page Trait section of the questionnaire will be administered and utilized.
Completed at baseline (T1) using REDCap.
Scores from 20-37 indicate low anxiety, 38-44 indicate moderate anxiety, and 45-80 indicate high anxiety.
|
Baseline (T1)
|
|
Changes in Children's Anxiety and Depression Assessed Using the Revised Child Anxiety and Depression Scale (RCADS)
Time Frame: Baseline (T1) , day 60 (T2) , and day 180 (T3)
|
The Revised Child Anxiety and Depression Scale (RCADS) -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.
TOTAL Scores range from 0-141.
|
Baseline (T1) , day 60 (T2) , and day 180 (T3)
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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)
Time Frame: Baseline (T1) , day 60 (T2) , and day 180 (T3)
|
Children and parents are asked to report on the child's health related quality of life.
The measure incorporates a generic (divided into 4 categories: physical, emotional, social and school), cancer (divided into 8 categories: pain & hurt, nausea, procedural anxiety, treatment anxiety, cognitive problems, perceived physical appearance and communication), and fatigue module (divided into 3 categories: general fatigue, sleep/rest fatigue, cognitive fatigue).
Higher scores on the scale suggest a better health related quality of life.
Questions are asked on a 5-point likert scale ranging from 0=never to 4=almost always.
Scores are transformed from 0-100.
TOTAL scores for each module range from 0-100 on the PedsQL.
|
Baseline (T1) , day 60 (T2) , and day 180 (T3)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle A Fortier, Ph.D., University of California, Irvine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20195027
- 1R01CA222012-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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