Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children With High Grade Brain Tumors and Their Caregivers

Background

- Children diagnosed with a high-grade brain tumor (e.g., diffuse intrinsic pontine
glioma, glioblastoma multiforme, high-grade astrocytoma) face a poor prognosis given
limited curative options.

- Recent research has indicated that this population of children and their parents
experience elevated stress and poorer health-related quality of life (HRQL) relative to
normative samples.

- Recently published psychosocial standards of care in pediatric oncology strongly
recommend that children diagnosed with cancer and their caregivers receive early and
continued assessment of their wellbeing and have access to interventions to optimize
functioning and HRQL. In addition, there is increasing recognition of the importance of
palliative interventions early in the disease trajectory.

- Despite this recommendation, minimal research has examined supportive care interventions
for this population early in the disease trajectory.

- Mindfulness-based interventions (MBIs) have empirical support for their feasibility and
efficacy in alleviating emotional distress and physical symptoms in children and adults
with chronic health conditions, including terminally-ill patients and their caregivers.

Objectives

-To assess the feasibility of an enhanced mindfulness intervention (EMI) in children (ages
5-17) with a high-grade brain tumor and one of their primary caregivers.

Eligibility

- Children ages 5-17 years and a parent or adult primary caregiver

- Diagnosis of a high-grade brain tumor

- English speaking

- Must have access to a mobile device or computer with internet.

- Potential participants will be excluded if there is evidence of pre-morbid severe
cognitive or psychiatric disability in parent or child that would impair their capacity
for participation, or if there is evidence of clinical disease progression at the time
of referral to this study, such that it would prevent the child from engaging in the
intervention.

Design

- This is a pilot randomized controlled trial that will compare feasibility and
preliminary efficacy of an 8-week EMI group (n=10 dyads) compared to a psychoeducation
control group (n=10 dyads).

- All participants will complete measures of feasibility (primary outcome) andexploratory
outcomes at baseline and following the 8-week intervention. Exploratory measures will
include emotional (e.g., depression, anxiety) and physical (e.g., pain, fatigue)
wellbeing, as well as baseline mindfulness/self-compassion.

- The 8-week EMI will consist of one initial in-person session with the child and parent,
a series of at-home assignments, and two booster sessions. The psychoeducation group
will be given educational material about coping with cancer.

- The psychoeducation group will be offered the opportunity to participate in the EMI 8
weeks post-baseline

- INCLUSION CRITERIA FOR CHILDREN:

- Patients must have a diagnosis of a high-grade brain tumor with active
disease,confirmed by medical record review. Note: A diagnosis of DIPG does not need a
biopsy to confirm high-grade.

- Patients with active disease

- Age greater than or equal to 5 years and less than or equal to 17 years of age

- Must be able to speak and understand English.

- Must have a parent or adult primary caregiver willing to participate in the study.

- Ability of Legally Authorized Representative to understand and the willing to sign a
written informed consent document.

- Must have access to a computer/mobile device and the internet.

EXCLUSION CRITERIA FOR CHILDREN:

- Patients will be excluded if there is evidence of pre-morbid severe cognitive or
psychiatric disability that would impair their capacity for participation or
completion of evaluations in the judgment of the investigators.

- Evidence of disease progression at the time of referral to this study to the extent
that it would impede participation or completion of evaluations as determined by the
medical advisory investigator in conjuction with the study PI/adjunct PI.

- Patients with treatment-related sequelae so severe that they would be unable to
complete the study-related evaluations or intervention (e.g., treatment toxicity) as
determined by the medical advisory investigator in conjuction with the study
PI/adjunct PI.

INCLUSION CRITERIA FOR PARENT OR ADULT PRIMARY CAREGIVER:

- Must be a parent or primary caregiver of a child (age 5 to 17 years of age) who has
been diagnosed with a high-grade brain tumor.

- Must have a child willing to participate in the study

- Must be able to speak and understand English.

- Ability of subject to understand and the willing to sign a written informed consent
document.

- Must have access to a computer/mobile device and the internet.