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Mindfulness-based Intervention for Teenagers With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01783418
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Catherine Malboeuf-Hurtubise, St. Justine's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Behavioral: Mindfulness Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : August 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ]

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

    Higher scores indicate higher anxiety and a worse outcome


  2. Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ]

    Pediatric Cancer Quality of Life Inventory

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


  3. Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ]

    Pittsburgh Sleep Quality Index

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

    Higher scores indicate worse outcomes


  4. Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: baseline, Post-intervention (8 weeks) ]

    Beck youth inventories - Depression scale

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

    Higher scores a worse outcome


  5. Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: baseline, Post-intervention (8 weeks) ]

    PANAS-C - Positive affect

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

    High scores represent better outcomes


  6. Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ]

    PANAS-C - Negative affect

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



Secondary Outcome Measures :
  1. Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention [ Time Frame: Baseline, Post-intervention (8 weeks) ]

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

    Higher scores represent better outcomes



Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783418


Locations
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Canada, Quebec
CHU Sainte-Justine, Mother and Child University Hospital Center
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Catherine Malboeuf-Hurtubise, Ph.D. Candidate, clinical psychology, Université de Montréal, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01783418    
Other Study ID Numbers: 3550
First Posted: February 4, 2013    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016
Last Verified: December 2015
Keywords provided by Catherine Malboeuf-Hurtubise, St. Justine's Hospital:
mindfulness-based meditation
pediatric cancer
adolescence
quality of life
 sleep
affect
health psychology