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NCT03538587 · FLOW

Participant flow

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.

groups
  1. description
    Arm 1/Enhanced Mindfulness Intervention (EMI) 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 child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
    id
    FG000
    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 dyads (= 1 child participant and 1 caregiver) in 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.
    id
    FG001
    title
    Arm 2 Control Group - Psychoeducation Group
periods
  1. milestones
    1. achievements
      1. comment
        2 dyads (each dyad = 1 child, 1 parent)
        group Id
        FG000
        num Subjects
        4
      2. comment
        3 dyads (each dyad = 1 child, 1 parent)
        group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Child Participants
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Parent Participants
    4. achievements
      1. comment
        1 dyad (each dyad = 1 child, 1 parent)
        group Id
        FG000
        num Subjects
        2
      2. comment
        1 dyad (each dyad = 1 child, 1 parent)
        group Id
        FG001
        num Subjects
        2
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Arm 1/Enhanced Mindfulness Intervention (EMI) 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 child participant and parent (= 1 dyad), a series of at home assignments, and two "booster" sessions.
    id
    FG000
    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 dyads (= 1 child participant and 1 caregiver) in 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.
    id
    FG001
    title
    Arm 2 Control Group - Psychoeducation Group
periods
  1. milestones
    1. achievements
      1. comment
        2 dyads (each dyad = 1 child, 1 parent)
        group Id
        FG000
        num Subjects
        4
      2. comment
        3 dyads (each dyad = 1 child, 1 parent)
        group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Child Participants
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Parent Participants
    4. achievements
      1. comment
        1 dyad (each dyad = 1 child, 1 parent)
        group Id
        FG000
        num Subjects
        2
      2. comment
        1 dyad (each dyad = 1 child, 1 parent)
        group Id
        FG001
        num Subjects
        2
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice