Mindfulness-based Intervention for Teenagers With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catherine Malboeuf-Hurtubise, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01783418
First received: January 29, 2013
Last updated: December 7, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Pediatric Cancer
Behavioral: Mindfulness Intervention

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

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score)

    Higher scores indicate higher anxiety and a worse outcome


  • Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    Pediatric Cancer Quality of Life Inventory

    Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes


  • Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    Pittsburgh Sleep Quality Index

    Score range: 0 (minimum score) - 21 (maximum score)

    Higher scores indicate worse outcomes


  • Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    Beck youth inventories - Depression scale

    Subscale range: 0 (minimum score) - 60 (maximum score)

    Higher scores a worse outcome


  • Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    PANAS-C - Positive affect

    Score range: 0 (minimum score) - 50 (maximum score)

    High scores represent better outcomes


  • Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    PANAS-C - Negative affect

    Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes



Secondary Outcome Measures:
  • Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ] [ Designated as safety issue: No ]

    Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score)

    Higher scores represent better outcomes



Enrollment: 15
Study Start Date: August 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness intervention Behavioral: Mindfulness Intervention
Mindfulness-based intervention adapted for teenagers
Active Comparator: Wait-list control Behavioral: Mindfulness Intervention
Mindfulness-based intervention adapted for teenagers

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783418

Locations
Canada, Quebec
CHU Sainte-Justine, Mother and Child University Hospital Center
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Catherine Malboeuf-Hurtubise, Ph.D. candidate Université de Montréal
Study Director: Marie Achille, Ph.D. Université de Montréal
Study Director: Serge Sultan, Ph.D. Université de Montréal, St. Justine's Hospital
Study Director: Majorie Vadnais, M.D. St. Justine's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Malboeuf-Hurtubise, Ph.D. Candidate, clinical psychology, Université de Montréal, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01783418     History of Changes
Other Study ID Numbers: 3550 
Study First Received: January 29, 2013
Results First Received: September 24, 2015
Last Updated: December 7, 2015
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by St. Justine's Hospital:
mindfulness-based meditation
pediatric cancer
adolescence
quality of life
sleep
affect
health psychology

ClinicalTrials.gov processed this record on July 27, 2016