NCT01783418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 12, 2016

Completed
Last Updated

January 12, 2016

Status Verified

December 1, 2015

Enrollment Period

2.1 years

First QC Date

January 29, 2013

Results QC Date

September 24, 2015

Last Update Submit

December 7, 2015

Conditions

Pediatric Cancer

Keywords

mindfulness-based meditationpediatric canceradolescencequality of lifesleepaffecthealth psychology

Outcome Measures

Primary Outcomes (6)

  • 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

    Baseline, Post-intervention (8 weeks)

  • 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

    Baseline, Post-intervention (8 weeks)

  • 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

    Baseline, Post-intervention (8 weeks)

  • 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

    baseline, Post-intervention (8 weeks)

  • 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

    baseline, Post-intervention (8 weeks)

  • 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

    Baseline, Post-intervention (8 weeks)

Secondary Outcomes (1)

  • Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention

    Baseline, Post-intervention (8 weeks)

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL
Behavioral: Mindfulness Intervention

Wait-list control

ACTIVE COMPARATOR
Behavioral: Mindfulness Intervention

Interventions

Mindfulness InterventionBEHAVIORAL

Mindfulness-based intervention adapted for teenagers

Mindfulness interventionWait-list control

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Teenagers (ages 12-18) with cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine, Mother and Child University Hospital Center

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23663534DERIVED

MeSH Terms

Conditions

Neoplasms

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

Results Point of Contact

Title
Catherine Malboeuf-Hurtubise, Post-doctoral fellow
Organization
Ste-Justine's Hospital
catherine.malboeuf-hurtubise@umontreal.ca
514-343-6111

Study Officials

  • Catherine Malboeuf-Hurtubise, Ph.D. candidate

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Candidate, clinical psychology, Université de Montréal

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 4, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 12, 2016

Results First Posted

January 12, 2016

Record last verified: 2015-12

Locations

CA(1)