Trial Outcomes & Findings for Mindfulness-based Intervention for Teenagers With Cancer (NCT NCT01783418)

Results Overview

Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score) Higher scores indicate higher anxiety and a worse outcome

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline, Post-intervention (8 weeks)

Results posted on

2016-01-12

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.

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.

Participant milestones

Participant milestones
Measure	Mindfulness Intervention Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Overall Study STARTED	8	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Intervention Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Mindfulness-based Intervention for Teenagers With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	Total n=13 Participants Total of all reporting groups
Age, Continuous	15.6 years STANDARD_DEVIATION 0.9 • n=5 Participants	15.3 years STANDARD_DEVIATION 2.2 • n=7 Participants	15.4 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention Baseline	18.9 units on a scale Standard Deviation 8.6	17.8 units on a scale Standard Deviation 6.9
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	12.8 units on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
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	77.9 units on a scale Standard Deviation 10.3
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	81.6 units on a scale Standard Deviation 7.3

PRIMARY outcome

Timeframe: Baseline, Post-intervention (8 weeks)

Pittsburgh Sleep Quality Index Score range: 0 (minimum score) - 21 (maximum score) Higher scores indicate worse outcomes

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention Baseline	8.5 units on a scale Standard Deviation 4.6	6.5 units on a scale Standard Deviation 3.7
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	5.8 units on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: baseline, Post-intervention (8 weeks)

Beck youth inventories - Depression scale Subscale range: 0 (minimum score) - 60 (maximum score) Higher scores a worse outcome

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention Baseline	15.8 units on a scale Standard Deviation 9.1	10.3 units on a scale Standard Deviation 5.6
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	9.2 units on a scale Standard Deviation 4.7

PRIMARY outcome

Timeframe: baseline, Post-intervention (8 weeks)

PANAS-C - Positive affect Score range: 0 (minimum score) - 50 (maximum score) High scores represent better outcomes

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention Baseline	27.4 units on a scale Standard Deviation 6.8	28.3 units on a scale Standard Deviation 4.5
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	27.0 units on a scale Standard Deviation 3.4

PRIMARY outcome

Timeframe: Baseline, Post-intervention (8 weeks)

PANAS-C - Negative affect Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention Baseline	19.7 units on a scale Standard Deviation 8.4	19.0 units on a scale Standard Deviation 4.0
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	16.3 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline, Post-intervention (8 weeks)

Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score) Higher scores represent better outcomes

Outcome measures

Outcome measures
Measure	Mindfulness Intervention n=7 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers	No Treatment Control n=6 Participants Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
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	27.8 units on a scale Standard Deviation 4.7
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	27.8 units on a scale Standard Deviation 4.7

Adverse Events

Mindfulness Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Malboeuf-Hurtubise, Post-doctoral fellow

Ste-Justine's Hospital

Phone: 514-343-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place