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Treating Pain in Children With Cancer: Pain Buddy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384134
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
The Hoag Foundation
American Cancer Society, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michelle Fortier, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Cancer Other: Pain Buddy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mobile Technology to Improve Pain and Symptoms in Children With Cancer
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

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.
Other: Pain Buddy
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.



Primary Outcome Measures :
  1. Changes in prevalence and intensity of pain episodes and other distressing physical and psychological symptoms. [ Time Frame: 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.

  2. Changes in pain severity, location, and affective dimensions [ Time Frame: 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).

  3. 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, day 30, and day 60 ]
    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.

  4. Changes in Children's Anxiety and Depression assessed using the Revised Child Anxiety and Depression Scale (RCADS) [ Time Frame: Baseline, day 30, and day 60 ]
    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.

  5. State-Trait Anxiety Inventory (STAI) (parent self-report) [ Time Frame: 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.

  6. Changes in Perceived Stress (parent self-report) [ Time Frame: Baseline, day 30, and day 60 ]
    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.

  7. Medication Attitude Questionnaire (MAQ) (parent self-report) [ Time Frame: 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").

  8. Child compliance with Pain buddy [ Time Frame: Day 60 ]
    Compliance will be assessed objectively via electronic time stamps from the Pain Buddy Program. Compliance of 80% or higher will be considered acceptable.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384134


Contacts
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Contact: Haydee Cortes, BA 714-456-2837 cortesh@uci.edu
Contact: Michelle A Fortier, Ph.D. 714-456-2833 mfortier@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Haydee Cortes, BA    714-456-2837    cortesh@uci.edu   
Contact: Michelle A Fortier, Ph.D.    714-456-2833    mfortier@uci.edu   
Sponsors and Collaborators
University of California, Irvine
The Hoag Foundation
American Cancer Society, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michelle A Fortier, Ph.D. University of California, Irvine
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Responsible Party: Michelle Fortier, Study Principal Investigator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03384134    
Other Study ID Numbers: 120111
1R01CA222012-01 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Fortier, University of California, Irvine:
cancer
cognitive and behavioral skills training intervention
pain
symptoms
quality of life