NCT03538587 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Date treatment consent signed to date off study, approximately 2-3 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group 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.	0 / 4	0 / 4	0 / 4
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.	0 / 6	0 / 6	0 / 6

Group identifiers: EG000: Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group · EG001: Arm 2 Control Group - Psychoeducation Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
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.
id
EG000
other Num Affected
0
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group
deaths Num Affected
0
deaths Num At Risk
6
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
EG001
other Num Affected
0
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Arm 2 Control Group - Psychoeducation Group

frequency Threshold

time Frame

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

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Preserved source evidence · Not medical advice