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Completed

NCT Number: NCT01783418

Mindfulness-based Intervention for Teenagers With Cancer

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.

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Key information

Conditions

Pediatric Cancer Neoplasms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine, Mother and Child University Hospital Center

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Intervention

Behavioral

Mindfulness-based intervention adapted for teenagers

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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