Pediatric Cancer
Conditions
Keywords
mindfulness-based meditation, pediatric cancer, adolescence, quality of life, sleep, affect, health psychology
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.
Interventions
BEHAVIORALMindfulness Intervention
Mindfulness-based intervention adapted for teenagers
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | 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 | 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 | Baseline, Post-intervention (8 weeks) | Pittsburgh Sleep Quality Index Score range: 0 (minimum score) - 21 (maximum score) Higher scores indicate worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Baseline, Post-intervention (8 weeks) | Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score) Higher scores represent better outcomes |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Intervention Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers | 7 |
| No Treatment Control Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Mindfulness Intervention | No Treatment Control | Total |
|---|---|---|---|
| Age, Continuous | 15.6 years STANDARD_DEVIATION 0.9 | 15.3 years STANDARD_DEVIATION 2.2 | 15.4 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment Canada | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
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
Time frame: baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 27.4 units on a scale | Standard Deviation 6.8 |
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 29.7 units on a scale | Standard Deviation 7.9 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 28.3 units on a scale | Standard Deviation 4.5 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 27.0 units on a scale | Standard Deviation 3.4 |
Comparison: Baseline, Post-intervention (8 weeks)p-value: 0.358ANOVA
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
Time frame: Baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 18.9 units on a scale | Standard Deviation 8.6 |
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 15.9 units on a scale | Standard Deviation 6.7 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 17.8 units on a scale | Standard Deviation 6.9 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 12.8 units on a scale | Standard Deviation 3.2 |
Comparison: Baseline and Post-intervention (8 weeks)p-value: 0.613ANOVA
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
Time frame: Baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 19.7 units on a scale | Standard Deviation 8.4 |
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 16.9 units on a scale | Standard Deviation 4.5 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 19.0 units on a scale | Standard Deviation 4 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 16.3 units on a scale | Standard Deviation 5.8 |
Comparison: Baseline, Post-intervention (8 weeks)p-value: 0.95ANOVA
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
Time frame: baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 15.8 units on a scale | Standard Deviation 9.1 |
| Mindfulness Intervention | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 9.8 units on a scale | Standard Deviation 5.2 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 10.3 units on a scale | Standard Deviation 5.6 |
| No Treatment Control | Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 9.2 units on a scale | Standard Deviation 4.7 |
Comparison: Baseline, Post-interventionp-value: 0.241ANOVA
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
Time frame: Baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 73.8 units on a scale | Standard Deviation 14.4 |
| Mindfulness Intervention | Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 77.4 units on a scale | Standard Deviation 11.8 |
| No Treatment Control | Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 77.9 units on a scale | Standard Deviation 10.3 |
| No Treatment Control | Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 81.6 units on a scale | Standard Deviation 7.3 |
Comparison: Baseline, Post-intervention (8 weeks)p-value: 0.957ANOVA
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
Time frame: Baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 8.5 units on a scale | Standard Deviation 4.6 |
| Mindfulness Intervention | Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 6.5 units on a scale | Standard Deviation 3.7 |
| No Treatment Control | Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 6.5 units on a scale | Standard Deviation 3.7 |
| No Treatment Control | Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 5.8 units on a scale | Standard Deviation 2.8 |
Comparison: Baseline, Post-intervention (8 weeks)p-value: 0.256ANOVA
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
Time frame: Baseline, Post-intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Intervention | Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 24.1 units on a scale | Standard Deviation 5.6 |
| Mindfulness Intervention | Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 27.3 units on a scale | Standard Deviation 7.3 |
| No Treatment Control | Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Baseline | 27.8 units on a scale | Standard Deviation 4.7 |
| No Treatment Control | Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention | Post-intervention (8 weeks) | 27.8 units on a scale | Standard Deviation 4.7 |
Comparison: Baseline, Post-intervention (8 weeks)p-value: 0.97ANOVA