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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• Glioblastoma 1,951
• Sarcoma 1,691
• Astrocytoma 434
• Brain Neoplasms 1,993
• Leukemia 5,475
• Diffuse Intrinsic Pontine Glioma 122

Keywords

• Refractory Metastatic Sarcoma
• Diffuse Intrinsic Pontine Glioma DIPG
• Relapsed-Refractory Leukemia
• Meditation
• Quality of Life

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Study 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.

  Behavioral: Enhanced Mindfulness Intervention

• 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

  Behavioral: Psychoeducation

Interventions

• BehavioralEnhanced 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.

• BehavioralPsychoeducation

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

Primary outcomes

1. Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period

   Percentage of eligible dyads (1 parent, 1 child) who enroll during a two-year period (the number of dyads who enrolled divided by the number of dyads who were found eligible).

   Time frame: 2 years

2. Percent of Participants (Parent/Child) With Treatment Specific Retention Among All Randomized Participants, With a Target Retention Rate of 70% Over the 8 Week EMI/Control Period

   Percent of participants who completed the study among those who enrolled and were randomized, with a target retention rate of 70% over the 8 Week EMI/control period.

   Time frame: 8 weeks from study entry

3. Percent of Participants Who Completed a Mean of 4 Days/Week At-home Practices or More

   Compliance with at-home practices (e.g., at home assignments), with a proposed target rate of at least 4 out of 7 days per week on average over the 8 weeks. This will be measured in phone interviews and recorded on a study form.

   Time frame: For 8 weeks from study entry

4. Score on a Scale for Caregiver/Children Reports of Satisfaction on the Feasibility Questionnaire

   The Feasibility questionnaire is a 12-item measure created by the researchers to assess satisfaction with the study. The first 6 items are on 5-point Likert scales and ask how helpful various aspects of the intervention were. Satisfaction scores are the mean of items 1-6 for both the caregiver and child forms, with possible scores ranging from 1 to 5. Higher scores represent more satisfaction. For youth ages 8+ and caregivers, average item scores of \>3.0 reflect adequate satisfaction.

   Time frame: 8 weeks from study entry

Other outcomes

1. Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

   Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

   Time frame: Date treatment consent signed to date off study, approximately 2-3 months.

Baseline characteristics

3 further baseline measures are reported on the registry.

Related links

• NIH Clinical Center Detailed Web Page ↗

Study documents

• Protocol and statistical analysis plan · Dec 13, 2021
• Informed consent form · Dec 13, 2021
• Informed consent form · Dec 13, 2021
• Informed consent form · Dec 13, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Clinical data available during the study and indefinitely.

Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).