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PAINBDY1: Treating Pain in Children with Cancer: Pain Buddy

Treating Pain in Children with Cancer: A 21st Century Innovative Approach (Pain Buddy)

Categories:

Psychology and Biobehavioral Medicine

Leukemia / Lymphoma

Quality of Life

Solid Tumor

Diseases Treated:

ALL
AML
Carcinoma
Endocrine Tumors
Lymphoma
Melanoma
Neuroblastoma
Retinoblastoma
Ewing Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Sarcomas

Eligibility Overview:

This is a research study open only to St. Jude patients and their caregivers.

  • 8 to 18 years old
  • Within 16 weeks of initial cancer diagnosis
  • Receiving outpatient chemotherapy treatment for cancer
  • Can speak, read and write English. Parents who can speak, read, and write in English and Spanish
  • Have Internet access
  1. Brief Summary

    This study will examine the feasibility of using an electronic diary to document pain, symptoms and quality of life in children receiving outpatient chemotherapy for cancer.

    Studies suggest computer-based decision-support has a positive impact on symptom management. In this trial, parents and patients will use a mobile app called Pain Buddy to track the prevalence and intensity of daily pain and other symptoms. Health care teams will use this data to develop appropriate psychosocial interventions to improve patients’ quality of life.

    Primary Objective

    To quantify the prevalence and intensity of daily pain episodes and other distressing physical and psychosocial symptoms in children receiving cancer treatment

    Eligibility Criteria

    Inclusion criteria include:

    • 8 to 18 years old
    • Within 16 weeks of initial cancer diagnosis
    • Currently undergoing outpatient chemotherapy treatment for cancer
    • Have experienced a pain score of 30 or greater on a visual analog scale in the past month
    • Can speak, read and write English. Parents can speak, read and write in English and Spanish
    • Have Internet access to use Pain Buddy on mobile device

    Exclusion Criteria include:

    • Cognitive impairment
    • Diagnosed with acute promyelocytic leukemia (APL)

    Study Sites

    • St. Jude Children’s Research Hospital, Memphis, Tennessee
    • Collaborating sites in the U.S.
  2. About this study

    This is a study to help us understand how often children have pain and symptoms during cancer treatment. We also want to find out the best ways to manage those symptoms.

    Studies have shown that computers, smart phones and other types of technology can help patients manage pain and symptoms.

    In this study, you will download an app called Pain Buddy. This app asks questions about quality of life, pain and other symptoms. Doctors will use the information to help treat these symptoms.

    You or your child may not benefit from participating in this study. However, what we learn from the study may benefit other patients in the future.

    Purpose of this clinical trial

    The main goal of this research study is to help us learn how to better treat pain and symptoms in children going through chemotherapy cancer treatment.

    Eligibility overview

    • 8 to 18 years old
    • Within 16 weeks of initial cancer diagnosis
    • Currently undergoing outpatient treatment for cancer
    • Speak, read and write English. Parents who can speak, read, and write in English and Spanish.
    • Have Internet access
  3. PAINBDY1
    Sponsors: University of California, Irvine
    ClinicalTrials.gov identifier NCT03384134
    Trial Start Date: August 2019
    Estimated Enrollment: 103 (42 at St. Jude)
    Study Type: Interventional
    Conditions: Cancer
    Ages: 8 to 18 years old
    Principal investigator: Ryan N. James, PhD
    Study Sites: St. Jude Children’s Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss PAINBDY1: St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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