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Pain Buddy App for Childhood Cancer

N/A

Waitlist Available

Led By Michelle A Fortier, Ph.D.

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 8-18 years

Currently undergoing outpatient treatment for cancer

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 60, and day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mobile app called Pain Buddy to see if it can help document a child's pain, symptoms, and quality of life while receiving outpatient chemotherapy. The goal is to use the data to develop a way to improve quality of life for children with cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since Pain Buddy is a monitoring tool rather than a medication, there aren't traditional side effects associated with its use; however, user satisfaction and any stress related to using the technology will be assessed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 18 years old.

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I am receiving cancer treatment without staying in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child does not have cognitive impairments that would prevent them from using a digital pain tracking program.

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My child does not have AML or APL leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Children's Anxiety and Depression assessed using the Revised Child Anxiety and Depression Scale (RCADS)

Changes in Perceived Stress (parent self-report)

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)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 4Eligibility criteria met