Mindfulness-Based Therapy for Brain Tumour Survivors
Primary Purpose
Brain Tumour, Depressive Symptoms, Survivors
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumour focused on measuring Mindfulness-based Therapy, Brain Tumour Survivors, Depressive Symptoms, Quality of Life, Perceived Stress, Wellbeing, Treatment
Eligibility Criteria
Inclusion Criteria:
- consenting brain tumour survivor at The Odette Cancer Centre
- >six months post-treatment
- Ability to communicate, in written and spoken English
Exclusion Criteria:
- Minimal depressive symptoms (score below 14 on the BDI-II)
- Previous head injuries or non-BT neurological diseases
- Unaware of deficits (determined through clinical judgement)
- Substance abuse / dependence within three months
- History of dementia, a recent suicide attempt, or current self-injurious behavior
- Previously completed >four weeks of a MBI, or general CBT, in the past three years
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness-based Therapy
Arm Description
5 week, manual-based group MBI treatment for depression
Outcomes
Primary Outcome Measures
Change from Baseline Depressive Symptoms at 5 Weeks
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
Secondary Outcome Measures
Change from Baseline Quality of Life at 5 Weeks
Scale used to measure Quality of Life: Quality of Life after Brain Injury (QOLBRI)
Change from Baseline Perceived Stress at 5 Weeks
Scale used to measure Perceived Stress: Perceived Stress Scale (PSS)
Change from Baseline Mental Wellbeing at 5 Weeks
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Full Information
NCT ID
NCT02792608
First Posted
May 26, 2016
Last Updated
June 5, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Brain Tumour Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT02792608
Brief Title
Mindfulness-Based Therapy for Brain Tumour Survivors
Official Title
A Mindfulness-Based Intervention to Improve Quality of Life Among Brain Tumour Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
November 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Brain Tumour Foundation of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and psychosocial sequelae. Unfortunately, to-date there has been very limited research into rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone1, access to effective, evidence-based rehabilitative treatment that would improve BT survivors' quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based Therapy's (MBTs) are emerging as a potential treatment to address this need. MBTs are group-based psychological treatments for coping with illness or disability, with the goal of improving psychological wellbeing. Recent studies have begun to suggest a role for MBTs in addressing symptom burden and QOL in the acquired brain injury (ABI) population, a heterogeneous population that includes survivors of stroke and traumatic brain injury, as well as BT survivors. High quality research including within-subject controlled trials, are needed to demonstrate whether MBTs can provide efficacious, accessible and cost-effective treatment to improve the lives of BT survivors.
Detailed Description
Increased survival rates and life expectancy of primary BT survivors today have resulted in a need to expand the focus from acute treatment to reducing disability and long-term symptom burden in survivorship. Many BT survivors are left with reduced autonomy in their lives, with a lower likelihood of independent living and increased risk of functional and symptom adversity (pain and physical disability), unemployment, and family difficulties. Unsurprisingly, these factors are associated with increased stress, psychological suffering, and reduced QOL. Research has noted the prevalence of psychological distress and cognitive impairment, experienced as late effects, with up to 90% of survivors experiencing some form of cognitive impairment and depressive symptoms, as well as many as 80% experiencing mental fatigue and up to 60% experiencing anxiety.
80% of all central nervous system tumour survivors exhibit rehabilitation needs, and survivors report an interest in learning coping techniques for stress, yet the majority of symptoms remain underestimated and untreated. BT survivors are left with limited treatment options to promote long-term wellbeing, with 71% of resources containing minimal to no information on coping with outcomes. Despite considerable research demonstrating BT survivors increased risk of symptom burden and reduced QOL, there has been little research on treatment or effective interventions.
Some outpatient rehabilitation therapies have been made available to other neurologically impaired populations (e.g. Traumatic Brain Injury, Stroke) but evidence in support of specific approaches has been equivocal, with limited rehabilitative research in BT survivors specifically. Such treatments for the broader ABI population to-date have included Cognitive Behavioural Therapy (CBT) and Applied Behavioural Analysis (ABA), with debatable effectiveness. Positive studies have suggested that treatment may only prove effective for a handful of ABI sequelae. Studies to date are marred by limited methodological rigour and applicability to the BT population because of the broader, heterogeneous ABI focus. As a result, healthcare professionals and national organizations, such as National Coalition for Cancer Survivorship, have called for higher quality research to inform novel treatments to improve outcomes for specific groups, such as the BT population.
In response to these calls, Mindfulness-Based Therapy's (MBTs) have been proposed as a plausible treatment for long term care of ABI survivors, in general. MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances. MBTs have good evidence that they improve a wide range of sequelae, including, stress, depression, anxiety and cognitive impairment. MBT efficacy has been repeatedly demonstrated across multiple psychiatric, neurological, and cancer populations. MBTs focus on acceptance-based and adaptive approaches, which might theoretically be better suited to the realities of the lives of BT survivors, than would change-based approaches such as CBT or ABA. MBT participants learn to generate less distress, engage more positively in their lives, and respond to difficult situations more adaptively; they often describe it as transformative.
MBTs have begun to be studied in the broader ABI survivor population, and this emerging literature suggests efficacy in reducing symptom burden. However, there are no known studies considering the effectiveness of an MBT for BT survivors specifically; the present study aims to fill this important knowledge gap. The goal of this study is to test the effectiveness of a five session MBT course in reducing depressive symptoms and perceived stress, as well as improving overall QOL and wellbeing for BT survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumour, Depressive Symptoms, Survivors
Keywords
Mindfulness-based Therapy, Brain Tumour Survivors, Depressive Symptoms, Quality of Life, Perceived Stress, Wellbeing, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based Therapy
Arm Type
Experimental
Arm Description
5 week, manual-based group MBI treatment for depression
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Therapy
Intervention Description
MBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
Primary Outcome Measure Information:
Title
Change from Baseline Depressive Symptoms at 5 Weeks
Description
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
Time Frame
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Secondary Outcome Measure Information:
Title
Change from Baseline Quality of Life at 5 Weeks
Description
Scale used to measure Quality of Life: Quality of Life after Brain Injury (QOLBRI)
Time Frame
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Title
Change from Baseline Perceived Stress at 5 Weeks
Description
Scale used to measure Perceived Stress: Perceived Stress Scale (PSS)
Time Frame
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Title
Change from Baseline Mental Wellbeing at 5 Weeks
Description
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consenting brain tumour survivor at The Odette Cancer Centre
>six months post-treatment
Ability to communicate, in written and spoken English
Exclusion Criteria:
Minimal depressive symptoms (score below 14 on the BDI-II)
Previous head injuries or non-BT neurological diseases
Unaware of deficits (determined through clinical judgement)
Substance abuse / dependence within three months
History of dementia, a recent suicide attempt, or current self-injurious behavior
Previously completed >four weeks of a MBI, or general CBT, in the past three years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Selchen, MD MSt FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Ellis, MB MD FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness-Based Therapy for Brain Tumour Survivors
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