Treating Pain in Children With Cancer: Pain Buddy

Approximately 12,000 children are diagnosed with cancer in the United States each year and
the majority of these children will experience moderate to severe pain and disabling symptoms
such as fatigue and nausea during the course of their illness. Survivors of childhood cancer
are also at high-risk for long-term chronic pain. Unfortunately, the World Health
Organization (WHO) indicates that current efforts to manage pain in pediatric oncology
patients are seriously inadequate. Reasons for under treatment of pain and symptoms in
children diagnosed with cancer are complex and are likely related to deficits in the process
of assessment and management as well as lack of timely access to pharmacological and
non-pharmacological interventions. Management of pain in this population is also compounded
by the fact that increasing numbers of children currently receive chemotherapy on an
outpatient basis due to advances in healthcare and changes in the medical-economical
environment.

To date, interventions targeting pain and symptom management in the home setting of children
suffering from cancer are seriously lacking. To address this significant gap, the candidate
is proposing significant training in pediatric cancer pain and symptom management and an
innovative two-phase research strategy. The first phase of research will focus on the
development and formative evaluation of an innovative handheld electronic program (Pain
Buddy) that provides remote monitoring of pain and symptoms and delivery of cognitive and
behavioral skills training to children undergoing treatment for cancer. The second phase of
this application involves evaluation of the efficacy of the program using a randomized
controlled trial design. Pain Buddy will allow for collection of "real time" pain and symptom
data that will be transmitted immediately and monitored remotely by the oncology treatment
team. Remote symptom monitoring in real time will provide an opportunity for timely
implementation of appropriate interventions, thereby introducing the potential to decrease
pain and symptoms and improve quality of life. Pain Buddy will also deliver psychosocial
skills training, teaching cognitive and behavioral strategies to manage pain and
symptom-related distress. The skills training will target coping and self-efficacy in
children without the need for face-to-face intervention which is not feasible in the majority
of settings. Symptom monitoring and skills training will further increase patient engagement
in their own health care, which is a main goal of the Institute of Medicine and many other
organizations. The objectives outlined above will be accomplished by the following specific
aims:

PHASE I: Development and Formative Evaluation Specific Aim 1: Through collaboration with the
California Institute for Telecommunications and Information Technology (Calit2), develop and
examine the usability of a cognitive and behavioral skills training intervention (Pain Buddy)
delivered via electronic, handheld technology in conjunction with a validated pain and
symptom assessment protocol (Jacob, E.) that will allow for monitoring of and response to
pain and symptoms of pediatric oncology patients in real time.

Hypothesis 1. Children and their parents will demonstrate the ability to use Pain Buddy on
the electronic device and will rate high levels of acceptability, usability and satisfaction
on beta testing.

PHASE II: Randomized Controlled Trial of Pain Buddy Specific Aim 2: Using a randomized
controlled trial design, we will examine the efficacy of Pain Buddy in managing pain and
symptoms in children suffering from cancer.

Hypothesis 2. Children enrolled in the Pain Buddy group will report lower symptom-related
distress as measured by the Memorial Symptom Assessment Scale (MSAS), compared to children in
the monitoring group (primary outcome).

Hypothesis 3. Children in the Pain Buddy group will evidence lower pain severity and higher
quality of life compared with children in the monitoring group (secondary outcomes).

Hypothesis 4. Children and nurses will demonstrate high rates of compliance (85% or greater)
with Pain Buddy (secondary outcome).

The long-term goals of this research are to develop a usable, engaging electronic
decision-support pain and symptom management intervention for children receiving outpatient
chemotherapy using Smartphone technology and to examine the efficacy of the electronic
decision-support intervention on children's pain and quality of life. These long-term goals
will be accomplished through assessment of the data collected from patients, parents and
physicians using the ambulatory monitoring protocol.

PHASE III: Multi-Site Randomized Controlled Trial of Pain Buddy

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

Secondary Aims:

1. Examine the impact of Pain Buddy on symptom-related distress as measured by the MSAS,
health related quality of life as measured by the PedsQL, child functional status as
measured by the CALI, and child and parent satisfaction with treatment experience as
measured by the TEI-SF.

2. Identify baseline characteristics of children (anxiety, pain catastrophizing) and
parents (stress, attitudes regarding analgesic use for children) that may
moderate/mediate treatment outcomes.

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.