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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness intervention | Experimental |
| |
| Wait-list control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Intervention | Behavioral | Mindfulness-based intervention adapted for teenagers |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Post-intervention (8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine, Mother and Child University Hospital Center | Montreal | Quebec | H3T 1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23663534 | Derived | 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. |
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Over 9 months of recruitment, 481 youth were screened for participation in this project. Of these, 418 (86.9%) were excluded because they lived further than 1 hour from the intervention site, had no history of cancer, had died or were not reachable by telephone. Recruitment for the control group was completed shortly after.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Intervention | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers |
| FG001 | No Treatment Control | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Intervention | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers |
| BG001 | No Treatment Control | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention (8 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Intervention | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers |
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Major recruitment and retention issues leading to very small number of subjects recruited and analyzed.
Small sample leading to underpowered study and uninterpretable data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Malboeuf-Hurtubise, Post-doctoral fellow | Ste-Justine's Hospital | 514-343-6111 | 4594 | catherine.malboeuf-hurtubise@umontreal.ca |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Baseline, Post-intervention (8 weeks) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention (8 weeks) |
|
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention (8 weeks) |
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| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention (8 weeks) |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline, Post-intervention (8 weeks) |
|
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline, Post-intervention (8 weeks) |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-intervention (8 weeks) |
|
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|
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| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | No Treatment Control | Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers | 0 | 6 | 0 | 6 |
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