Pediatric CancerNCT01783418

Mindfulness-based Intervention for Teenagers With Cancer

A study testing Mindfulness Intervention in people with Pediatric Cancer, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Pediatric Cancer
What is being tested?: Mindfulness Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteCanada
Study dates: Aug 2012to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Teenagers (ages 12-18) with cancer

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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.

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.

Conditions: Pediatric Cancer
Being tested: Mindfulness Intervention
Keywords: mindfulness-based meditation, pediatric cancer, adolescence, quality of life, sleep, affect, health psychology
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness InterventionBehavioural
Mindfulness-based intervention adapted for teenagers

Study groups in NCT01783418
Study group	Role	What they receive
Mindfulness intervention	Experimental	Not described Receives: Behavioral: Mindfulness Intervention
Wait-list control	Active comparator	Not described Receives: Behavioral: Mindfulness Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Post-intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Sep 2014

First posted4 Feb 2013 (estimated)
Study startAug 2012
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01783418
Sponsor's protocol ID: 3550
Status last verified: Dec 2015
First submitted: 29 Jan 2013
Last updated: 12 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediatric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01783418
Acronym / sponsor ID: 3550
Conditions: Pediatric Cancer
Keywords: mindfulness-based meditation, pediatric cancer, adolescence, quality of life, sleep, affect, health psychology
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: St. Justine's HospitalUniversity, hospital or other
Study start: Aug 2012
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 12 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Mindfulness intervention	Experimental	Behavioral: Mindfulness Intervention
Wait-list control	Active comparator	Behavioral: Mindfulness Intervention

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Teenagers (ages 12-18) with cancer

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness InterventionMindfulness-based intervention adapted for teenagers	Behavioural	Mindfulness intervention, Wait-list control

Primary outcome

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
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
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
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
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
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

1 secondary outcome

Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention
Time frame: Baseline, Post-intervention (8 weeks)

Results and safety

Results posted to the registry on 12 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness Intervention	8	7
No Treatment Control	6	6

Primary outcome: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention

Time frame: Baseline, Post-intervention (8 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Mindfulness Intervention n = 7	No Treatment Control n = 6
Baseline	18.9 (8.6)	17.8 (6.9)
Post-intervention (8 weeks)	15.9 (6.7)	12.8 (3.2)

Mindfulness Intervention vs No Treatment Control: p = 0.613, ANOVA

Primary outcome: Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention

Time frame: Baseline, Post-intervention (8 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Mindfulness Intervention n = 7	No Treatment Control n = 6
Baseline	73.8 (14.4)	77.9 (10.3)
Post-intervention (8 weeks)	77.4 (11.8)	81.6 (7.3)

Mindfulness Intervention vs No Treatment Control: p = 0.957, ANOVA

Primary outcome: Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention

Time frame: Baseline, Post-intervention (8 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Mindfulness Intervention n = 7	No Treatment Control n = 6
Baseline	8.5 (4.6)	6.5 (3.7)
Post-intervention (8 weeks)	6.5 (3.7)	5.8 (2.8)

Mindfulness Intervention vs No Treatment Control: p = .256, ANOVA

Primary outcome: Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention

Time frame: baseline, Post-intervention (8 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Mindfulness Intervention n = 7	No Treatment Control n = 6
Baseline	15.8 (9.1)	10.3 (5.6)
Post-intervention (8 weeks)	9.8 (5.2)	9.2 (4.7)

Mindfulness Intervention vs No Treatment Control: p = 0.241, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Intervention	0 of 7 (0%)	0 of 7 (0%)	Not reported
No Treatment Control	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): Major recruitment and retention issues leading to very small number of subjects recruited and analyzed. Small sample leading to underpowered study and uninterpretable data

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23663534Malboeuf-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.

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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Intervention in people with Pediatric Cancer, run by St. Justine's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention (time frame: Baseline, Post-intervention (8 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01783418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.