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NCT03538587 · OUTCOME

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

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
NUMBER
Unit
percentage of participants(parent/child)
Interval / dispersion
Not reported
Time frame
8 weeks from study entry

What was measured

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.

Groups in this outcome

Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group

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.

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 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.

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 percentage of participants(parent/child) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group50Not reportedNot reportedNot reportedNot reported
Arm 2 Control Group - Psychoeducation Group33Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    units
    Participants
description
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.
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
    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 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
    OG001
    title
    Arm 2 Control Group - Psychoeducation Group
param Type
NUMBER
reporting Status
POSTED
time Frame
8 weeks from study entry
title
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
type
PRIMARY
unit Of Measure
percentage of participants(parent/child)

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

Preserved source evidence · Not medical advice