Mindfulness-based Intervention for Teenagers With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of a mindfulness-based meditation intervention on quality of life, sleep and mood in adolescents with cancer compared to a control group.

Official Title
-----------------
A Randomized, Wait-list Controlled Clinical Trial: the Effects of a Mindfulness-based Intervention on Quality of Life, Sleep and Mood in Adolescents With Cancer.

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teenagers (ages 12-18) with cancer Exclusion Criteria: No ongoing or lifetime severe psychopathology, such as schizophrenia, psychosis, delusional disorders or organic mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness intervention<br> | Behavioral: Mindfulness Intervention<br>* Mindfulness-based intervention adapted for teenagers<br>|
| Active Comparator: Wait-list control<br> | Behavioral: Mindfulness Intervention<br>* Mindfulness-based intervention adapted for teenagers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score) Higher scores indicate higher anxiety and a worse outcome | Baseline, Post-intervention (8 weeks) | 
| Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention | Pediatric Cancer Quality of Life Inventory Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes | Baseline, Post-intervention (8 weeks) | 
| Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention | Pittsburgh Sleep Quality Index Score range: 0 (minimum score) - 21 (maximum score) Higher scores indicate worse outcomes | Baseline, Post-intervention (8 weeks) | 
| Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Beck youth inventories - Depression scale Subscale range: 0 (minimum score) - 60 (maximum score) Higher scores a worse outcome | baseline, Post-intervention (8 weeks) | 
| Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | PANAS-C - Positive affect Score range: 0 (minimum score) - 50 (maximum score) High scores represent better outcomes | baseline, Post-intervention (8 weeks) | 
| Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | PANAS-C - Negative affect Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes | Baseline, Post-intervention (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score) Higher scores represent better outcomes | Baseline, Post-intervention (8 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness-based meditation, pediatric cancer, adolescence, quality of life, sleep, affect, health psychology