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CompletedNCT01783418Updated Jan 12, 2016Results posted

Mindfulness-based Intervention for Teenagers With Cancer

An interventional study of Mindfulness Intervention in Pediatric Cancer, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-01-12.

Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Cancer

Keywords

  • mindfulness-based meditation
  • pediatric cancer
  • adolescence
  • quality of life
  • sleep
  • affect
  • health psychology
03

In context

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Teenagers (ages 12-18) with cancer

Exclusion criteria

Exclusion Criteria:

  • No ongoing or lifetime severe psychopathology, such as schizophrenia, psychosis, delusional disorders or organic mental disorders
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Mindfulness intervention

    Behavioral: Mindfulness Intervention

  • Active comparator
    Wait-list control

    Behavioral: Mindfulness Intervention

Interventions

  • BehavioralMindfulness Intervention

    Mindfulness-based intervention adapted for teenagers

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, Post-intervention (8 weeks)

  2. 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

    Time frame: Baseline, Post-intervention (8 weeks)

  3. 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

    Time frame: Baseline, Post-intervention (8 weeks)

  4. 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

    Time frame: baseline, Post-intervention (8 weeks)

  5. 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

    Time frame: baseline, Post-intervention (8 weeks)

  6. 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

    Time frame: Baseline, Post-intervention (8 weeks)

Secondary outcomes

  1. 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

    Time frame: Baseline, Post-intervention (8 weeks)

07

Results

Posted Jan 12, 2016
Limitations and caveats
Major recruitment and retention issues leading to very small number of subjects recruited and analyzed. Small sample leading to underpowered study and uninterpretable data

Participant flow

In the experimental condition, over 9 months of recruitment, 481 youth were screened for participation in this project. Of these, 418 were excluded. Of the 63 remaining, only 13 agreed to participate, gave their consent, and provided a complete dataset.

Participant flow — Overall Study
MilestoneMindfulness InterventionNo Treatment Control
Started86
Completed76
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryChanges 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

Time frame:
Baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline18.9 ± 8.617.8 ± 6.9
Post-intervention (8 weeks)15.9 ± 6.712.8 ± 3.2
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.613
PrimaryChanges 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

Time frame:
Baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline73.8 ± 14.477.9 ± 10.3
Post-intervention (8 weeks)77.4 ± 11.881.6 ± 7.3
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.957
PrimaryChanges 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

Time frame:
Baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline8.5 ± 4.66.5 ± 3.7
Post-intervention (8 weeks)6.5 ± 3.75.8 ± 2.8
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = .256
SecondaryChanges 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

Time frame:
Baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline24.1 ± 5.627.8 ± 4.7
Post-intervention (8 weeks)27.3 ± 7.327.8 ± 4.7
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.97
PrimaryChanges 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

Time frame:
baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline15.8 ± 9.110.3 ± 5.6
Post-intervention (8 weeks)9.8 ± 5.29.2 ± 4.7
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.241
PrimaryChanges 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

Time frame:
baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline27.4 ± 6.828.3 ± 4.5
Post-intervention (8 weeks)29.7 ± 7.927.0 ± 3.4
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.358
PrimaryChanges 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

Time frame:
Baseline, Post-intervention (8 weeks)
Reported as:
Mean · units on a scale
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention
units on a scaleMindfulness InterventionNo Treatment Control
Baseline19.7 ± 8.419.0 ± 4.0
Post-intervention (8 weeks)16.9 ± 4.516.3 ± 5.8
Statistical analysis
  • Mindfulness Intervention vs No Treatment Control · ANOVA · p = 0.95

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mindfulness Intervention—0/7 (0%)0/7 (0%)
No Treatment Control—0/6 (0%)0/6 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mindfulness InterventionNo Treatment ControlTotal
Mean15.6 ± 0.915.3 ± 2.215.4 ± 1.5
Sex: Female, Male
Sex: Female, Male(Participants)Mindfulness InterventionNo Treatment ControlTotal
Female459
Male314
Region of Enrollment
Region of Enrollment(participants)Mindfulness InterventionNo Treatment ControlTotal
Canada7613
08

Study locations

1 site
  • CHU Sainte-Justine, Mother and Child University Hospital Center
    Montreal, Quebec H3T 1C5, Canada
09

References and documents

Publications

  • Malboeuf-Hurtubise C, Achille M, Sultan S, Vadnais M. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial. Trials. 2013 May 10;14:135. doi: 10.1186/1745-6215-14-135. PubMed 23663534 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01783418
Lead sponsor
St. Justine's Hospital
Responsible party
Catherine Malboeuf-Hurtubise (Ph.D. Candidate, clinical psychology, Université de Montréal, St. Justine's Hospital) — Principal investigator
First posted
Feb 4, 2013
Start date
Aug 2012
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Jan 12, 2016
Last update
Jan 12, 2016

Study contacts

Catherine Malboeuf-Hurtubise, Ph.D. candidate
principal investigator · Université de Montréal
Marie Achille, Ph.D.
study director · Université de Montréal
Serge Sultan, Ph.D.
study director · Université de Montréal, St. Justine's Hospital
Majorie Vadnais, M.D.
study director · St. Justine's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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