Clinical Trial Finder

• - 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 conjunction with the study principal investigator (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 conjunction 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.

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 enhanced mindfulness intervention (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

Arms

Active Comparator: Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group

Participate in an in-person session followed by a series of at-home assignments, and two booster sessions.

Active Comparator: Arm 2 Control Group - Psychoeducation Group

Participants will briefly meet with a member of the research team who will assess parent and child coping, and provide the child- caregiver dyad educational material about coping with cancer

Interventions

Behavioral: - Enhanced Mindfulness Intervention

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

Behavioral: - Psychoeducation

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