Treating Pain in Children With Cancer: Pain Buddy

NCT03384134 | Completed DMC

• 2 other identifiers: 201950271R01CA222012-01
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

cancer; cognitive and behavioral skills training intervention; pain; symptoms; quality of life

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Pain Buddy

EXPERIMENTAL

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.

Other: Pain Buddy

Control

NO INTERVENTION

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.

Interventions

Pain Buddy OTHER

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.

Pain Buddy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• American Cancer Society, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle A Fortier, Ph.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: Following informed consent, participants will be randomized to the intervention or control group using a blocked randomization scheme with block size equal to 4 and stratified by age group, gender and diagnosis. An online program to will be used to derive an assignment. Patients will be randomized at a 1:1 ratio with equal numbers randomized to the intervention and control groups.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 27, 2017
• Study Start: August 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 16, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)