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

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ClinicalTrials.gov Identifier: NCT03538587
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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 with high-grade brain tumors and their caregivers.

Objective:

To learn if mindfulness is feasible and acceptable for young people with high-grade brain tumors and their caregivers.

Eligibility:

Children ages 5 17 with a high-grade brain tumor, 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.


Condition or disease Intervention/treatment Phase
Gliomas Glioblastomas Astrocytoma Brain Neoplasm Brain Cancer Behavioral: Enhanced Mindfulness Intervention Behavioral: Psychoeducation Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children With High Grade Brain Tumors and Their Caregivers
Estimated Study Start Date : February 25, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
Active Comparator: 1/EMI Group
Participate in an in-person session followed by a series of at-home assignments, and two booster sessions
Behavioral: Enhanced Mindfulness Intervention
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.

Active Comparator: 2/Control 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
Behavioral: Psychoeducation
The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 8 weeks from study entry ]
    Descriptive and summary statistics will be used to report parent and child ratings of intervention completion, as well as satisfaction with the intervention via responses on a feasibility questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538587


Contacts
Contact: Andrea (Andy) F Gillespie, R.N. (240) 760-6185 gillesan@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03538587     History of Changes
Other Study ID Numbers: 180080
18-C-0080
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: January 7, 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
high-grade astrocytoma
Diffuse Intrinsic Pontine Glioma
Glioblastoma Multiforme
Meditation
Quality of Life

Additional relevant MeSH terms:
Glioblastoma
Glioma
Brain Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases