Mindfulness-based Intervention for Teenagers With Cancer

Pediatric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783418
• Other study ID #: 3550
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: December 7, 2015
• Start date: August 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Mindfulness Intervention
Mindfulness-based intervention adapted for teenagers

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine, Mother and Child University Hospital Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No