Mindfulness-based Intervention for Teenagers With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by St. Justine's Hospital
Sponsor:
Information provided by (Responsible Party):
Catherine Malboeuf-Hurtubise, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01783418
First received: January 29, 2013
Last updated: January 31, 2013
Last verified: January 2013
  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: Crossover 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.

Resource links provided by NLM:


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, 8 weeks, 6 months ] [ Designated as safety issue: No ]
    Beck Youth Inventories TM - Depression and anxiety scales Positive and Negative Affect Schedule - Child (PANAS-C)

  • Changes in quality of life from baseline to post-intervention and 6 months post-intervention [ Time Frame: Baseline, 8 weeks, 6 months ] [ Designated as safety issue: No ]
    Pediatric Cancer Quality of Life Inventory

  • Changes sleep from baseline to post-intervention and 6 months post-intervention [ Time Frame: Baseline, 8 weeks, 6 months ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index


Secondary Outcome Measures:
  • Changes in mindfulness propensity and skills from baseline to post-intervention and 6 months post-intervention [ Time Frame: Baseline, 8 weeks, 6 months ] [ Designated as safety issue: No ]
    Children and Adolescent Mindfulness Measure


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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
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

Contacts
Contact: Catherine Malboeuf-Hurtubise, Ph.D. candidate 1-514-343-6111 ext 4594 catherine.malboeuf-hurtubise@umontreal.ca
Contact: Majorie Vadnais, M.D. 1-514-345-4931 ext 5712 majorie.vadnais.hsj@ssss.gouv.qc.ca

Locations
Canada, Quebec
CHU Sainte-Justine, Mother and Child University Hospital Center Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Majorie Vadnais, M.D.    1-514-345-4931 ext 5712    majorie.vadnais.hsj@ssss.gouv.qc.ca   
Principal Investigator: Catherine Malboeuf-Hurtubise, Ph.D. candidate         
Sub-Investigator: Majorie Vadnais, M.D.         
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

No publications provided by St. Justine's Hospital

Additional 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
Last Updated: January 31, 2013
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 29, 2014