NCT03538587 · OUTCOME

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

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: score on a scale
Interval / dispersion: Not reported
Time frame: 8 weeks from study entry

What was measured

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.

Analysis population: Each dyad = 1 child, 1 parent. Half a dyad was analyzed in group 1 (i.e., 1 child), and 1 dyad (i.e., 1 child, 1 parent) was analyzed in group 2. Measure type "Number" is used instead of "Mean" because you cannot compute a mean from only one data point. Unfortunately, not enough participants completed this study measure to calculate means and standard deviations.

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

Group	Source count
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group	1
Arm 2 Control Group - Psychoeducation Group	2

Reported measurements

Child Participants

Analysis denominator · Participants

Group	Source count
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group	1
Arm 2 Control Group - Psychoeducation Group	1

Values in score on a scale · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group	1.83	Not reported	Not reported	Not reported	Not reported
Arm 2 Control Group - Psychoeducation Group	3.5	Not reported	Not reported	Not reported	Not reported

Parent Participants

Analysis denominator · Participants

Group	Source count
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group	0
Arm 2 Control Group - Psychoeducation Group	1

Values in score on a scale · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 2 Control Group - Psychoeducation Group	3.67	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.83
group Id
OG001
value
3.5
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
units
Participants
title
Child Participants
categories
measurements
group Id
OG001
value
3.67
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
units
Participants
title
Parent Participants

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants

description

groups

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
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

population Description

Each dyad = 1 child, 1 parent. Half a dyad was analyzed in group 1 (i.e., 1 child), and 1 dyad (i.e., 1 child, 1 parent) was analyzed in group 2. Measure type "Number" is used instead of "Mean" because you cannot compute a mean from only one data point. Unfortunately, not enough participants completed this study measure to calculate means and standard deviations.

reporting Status

POSTED

time Frame

8 weeks from study entry

title

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

type

PRIMARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice