Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for children aged 8-18 with cancer, undergoing outpatient treatment. They must be able to speak, read, and write in English (or their parents in English/Spanish), have home internet access for Pain Buddy use. Children with AML or APL or cognitive impairments are excluded.Inclusion Criteria
I am between 8 and 18 years old.
I can speak, read, and write in English or Spanish.
I am receiving cancer treatment without staying in the hospital.
+2 more
Exclusion Criteria
My child does not have cognitive impairments that would prevent them from using a digital pain tracking program.
My child does not have AML or APL leukemia.
Participant Groups
Pain Buddy is being tested to see if it can help monitor pain and improve quality of life for children receiving chemotherapy at home. It's a mobile health tech tool that tracks daily pain and symptoms to aid in managing treatments effectively.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain BuddyExperimental Treatment1 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 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.
Group II: ControlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, IrvineOrange, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
American Cancer Society, Inc.Collaborator
National Cancer Institute (NCI)Collaborator