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

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ClinicalTrials.gov Identifier: NCT03538587
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
Official Title  ICMJE Feasibility and Preliminary Efficacy of an Enhanced Mindfulness- Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers: A Pilot Randomized Controlled Trial
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 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.

...

Detailed Description

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Glioblastomas
  • Sarcoma
  • Astrocytoma
  • Brain Cancer
  • Leukemia
Intervention  ICMJE
  • 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.
  • Behavioral: Psychoeducation
    The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline
Study Arms  ICMJE
  • Active Comparator: 1/EMI Group
    Participate in an in-person session followed by a series of at-home assignments, and two booster sessions
    Intervention: Behavioral: Enhanced Mindfulness Intervention
  • 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
    Intervention: Behavioral: Psychoeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Andrea (Andy) F Gillespie, R.N. (240) 760-6185 gillesan@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538587
Other Study ID Numbers  ICMJE 180080
18-C-0080
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 27, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP