Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
Background:

 People cope with cancer in different ways. Mindfulness means focusing on the present moment
 with an open mind. Researchers want to see if this can help children and young adults with a
 high-grade high-risk cancer with poor prognosis.

 Objective:

 To learn if mindfulness is feasible and acceptable for children and young people with
 high-grade high-risk cancer with poor prognosis and their caregivers.

 Eligibility:

 Children ages 5 24 with a high-grade or high-risk cancer, with a caregiver who agrees to do
 the study

 Must have internet access (participants may borrow an iPod for the study)

 Must speak English

 Design:

 All participants will complete questionnaires. These will be about feelings, physical
 well-being, quality of life, and mindfulness.

 Researchers will review children s medical records.

 Participants will be randomly put in the mindfulness group or the standard care group.

 Participants in the standard care group will:

 Get general recommendations for coping with cancer

 Have check-in sessions 1 and 3 weeks after starting. These will last about 10 minutes each.

 After participants finish the standard care group, they may be able to enroll in the
 mindfulness group.

 Participants in the mindfulness group will:

 Attend an in-person mindfulness training session. The child participant will meet with one
 research team member for 90 minutes while the parent participant meets with another. Then
 they will come together for a half hour.

 Practice mindfulness exercises at least 4 days a week for 8 weeks.

 Be asked to respond to weekly emails or texts asking about their mindfulness practice

 Get a mindfulness kit with things to help them do their mindfulness activities at home.

 Have a 30-minute check-in with their coach 1 and 3 weeks after starting. This can be in
 person or by video chat.

 All participants (from both groups) will be asked to answer follow-up questions about 8 and
 16 weeks after starting the study. Participants will be paid $20 for each set of
 questionnaires they complete to thank them for their time.

 ...
Background

 -  Children and young adults diagnosed with a high-grade or high-risk cancer (e.g., diffuse
 intrinsic pontine glioma, glioblastoma multiforme, relapsed-refractory leukemia,
 refractory metastatic sarcomas) face a poor prognosis given limited curative options.

 -  Recent research has indicated that this population of patients 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 and
 young adults (ages 5-24 years) with a high-grade or high-risk cancer with poor prognosis and
 one of their primary caregivers.

 Eligibility

 -  Children and young adults ages 5-24 years and a parent or adult primary caregiver

 -  Diagnosis of a high-grade or high-risk cancer with poor prognosis

 -  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) and exploratory
 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 diagnosed with a high-risk/high-grade cancer (e.g., high-grade brain tumors,
 relapsed/refractory acute lymphoblastic leukemia, acute myeloid leukemia, high-grade
 sarcoma) characterized by poor prognosis (e.g., estimated 5-year survival rate <30%
 based on scientific consensus in the literature, where available, or by expert
 physician report), as confirmed by medical record review.

 -  Patients with active disease

 -  Age greater than or equal to 5 years and less than or equal to 24 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 subject or parent/guardian 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 PATIENTS:

 -  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 24 years of age) who has
 been diagnosed with a high-grade/high risk tumor that carries poor prognosis (as
 defined above); and must live in the same household as the patient for a majority of
 the time.

 -  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.