Pain Buddy for Reducing Pain in Children Undergoing Cancer Treatment

Status: closed to accrual

This trial studies how well an application, Pain Buddy, works in documenting pain, symptoms, and quality of life and reducing pain severity in children undergoing cancer treatment. Pain Buddy may be used to measure pain and symptoms in patients undergoing cancer treatment. This trial may help researchers and healthcare providers better treat pain and disable symptoms such as fatigue and nausea.

Inclusion Criteria

Are within 16 weeks of first time cancer diagnosis
Currently undergoing outpatient treatment for cancer
Have experienced a pain score of 30 or greater on a visual analog scale in the past month
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 internet access to use Pain Buddy on their mobile devices (the internet will be used to securely send the pain information to the research team)

Exclusion Criteria

Cognitive impairment, such as a developmental delay that would impact the child’s ability to use the Pain Buddy program
Children diagnosed with acute promyelocytic leukemia (APL) as the treatment protocols for these children are largely inpatient, precluding use of the intervention

PRIMARY OBJECTIVE:

I. Determine if Pain Buddy is more effective than an attention control in reducing pain severity among children ages 8-18 years old undergoing outpatient cancer treatment.

SECONDARY OBJECTIVES:

I. Examine the impact of Pain Buddy on symptom-related distress, health-related quality of life, functional status, and satisfaction with treatment experience.

II. Determine whether baseline characteristics of children (emotional functioning) and parents (stress, attitudes regarding analgesic use for children) moderate the effect of Pain Buddy on pain severity.

III. To examine how parents and children report anxiety and depressive symptoms of children (Revised Child Anxiety and Depression Scale [RCADS] sample).

IV. To assess the types of medication that were used to manage pain and symptoms, specifically opioid usage.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ATTENTION CONTROL): Patients receive standard of care for pain and symptom management. Patients also complete pain and symptom diaries on the Pain Buddy application over 5 minutes twice daily (BID) for 60 days.

GROUP II (PAIN BUDDY): Patients receive standard of care for pain and symptom management. Patients complete pain and symptom diaries on the Pain Buddy application over 5 minutes BID for 60 days. Patients also receive cognitive and behavioral coping skills training through the Pain Buddy program to manage pain and symptom-related distress.

After completion of intervention, patients are followed up at 6 months.

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Pain Buddy for Reducing Pain in Children Undergoing Cancer Treatment

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