Cancer Clinical Trial
Official title:
Mobile Technology to Improve Pain and Symptoms in Children With Cancer
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | American Cancer Society, Inc., National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in prevalence and intensity of pain episodes and other distressing physical and psychological symptoms. | 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. | Baseline and day 60 | |
Primary | Changes in pain severity, location, and affective dimensions | 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). | Baseline and day 60 | |
Primary | 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) | 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. | Baseline, day 60, and day 180 | |
Primary | Changes in Children's Anxiety and Depression assessed using the Revised Child Anxiety and Depression Scale (RCADS) | 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. | Baseline, day 60, and day 180 | |
Primary | State-Trait Anxiety Inventory (STAI) (parent self-report) | 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. | Baseline | |
Primary | Changes in Perceived Stress (parent self-report) | 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. | Baseline, day 60, and day 180 | |
Primary | Medication Attitude Questionnaire (MAQ) (parent self-report) | 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"). | Baseline |
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