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NCT03538587 · OUTCOME

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

Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Date treatment consent signed to date off study, approximately 2-3 months.

What was measured

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.

Groups in this outcome

Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group

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. 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.

Arm 2 Control Group - Psychoeducation Group

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group4
Arm 2 Control Group - Psychoeducation Group6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group0Not reportedNot reportedNot reportedNot reported
Arm 2 Control Group - Psychoeducation Group0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    units
    Participants
description
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.
groups
  1. description
    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. 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.
    id
    OG000
    title
    Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
  2. description
    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. Psychoeducation: The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline.
    id
    OG001
    title
    Arm 2 Control Group - Psychoeducation Group
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 2-3 months.
title
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice