Brain TumourNCT02792608
Mindfulness-Based Therapy for Brain Tumour Survivors
A study testing Mindfulness-based Therapy in people with Brain Tumour and Depressive Symptoms, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Tumour, Depressive Symptoms, Survivors
- What is being tested?
- Mindfulness-based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to 23 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consenting brain tumour survivor at The Odette Cancer Centre
- >six months post-treatment
- Ability to communicate, in written and spoken English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mindfulness-Based Intervention to Improve Quality of Life Among Brain Tumour Survivors
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.
Read the 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.
- Conditions
- Brain Tumour, Depressive Symptoms, Survivors
- Being tested
- Mindfulness-based Therapy
- Keywords
- Mindfulness-based Therapy, Brain Tumour Survivors, Depressive Symptoms, Quality of Life, Perceived Stress, Wellbeing, Treatment
- Medical subject headings
- Brain Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based TherapyBehavioural
MBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Therapy | Experimental | 5 week, manual-based group MBI treatment for depression Receives: Behavioral: Mindfulness-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depressive Symptoms at 5 Weeks
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
Measured: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Secondary outcomes (3)
Change from Baseline Quality of Life at 5 Weeks
Scale used to measure Quality of Life: Quality of Life after Brain Injury (QOLBRI)
Measured: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Change from Baseline Perceived Stress at 5 Weeks
Scale used to measure Perceived Stress: Perceived Stress Scale (PSS)
Measured: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Change from Baseline Mental Wellbeing at 5 Weeks
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Measured: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumourStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Tumour Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Steven Selchen, MD MSt FRCPC, Principal investigator, Sunnybrook Health Sciences CentreJanet Ellis, MB MD FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792608
- Sponsor's protocol ID
- 169-2015
- Status last verified
- Jun 2018
- First submitted
- 26 May 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Intervention to Improve Quality of Life Among Brain Tumour Survivors
- ClinicalTrials.gov ID
- NCT02792608
- Acronym / sponsor ID
- 169-2015
- Conditions
- Brain Tumour, Depressive Symptoms, Survivors
- Keywords
- Mindfulness-based Therapy, Brain Tumour Survivors, Depressive Symptoms, Quality of Life, Perceived Stress, Wellbeing, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Brain Tumour Foundation of Canada
- Study start
- Aug 2016 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Therapy | Experimental | Behavioral: Mindfulness-based Therapy5 week, manual-based group MBI treatment for depression |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- consenting brain tumour survivor at The Odette Cancer Centre
- >six months post-treatment
- Ability to communicate, in written and spoken English
Key exclusion criteria (6 listed)
- 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
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-based TherapyMBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group. | Behavioural | Mindfulness-based Therapy |
Primary outcome
Change from Baseline Depressive Symptoms at 5 Weeks
Time frame: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
3 secondary outcomes
Change from Baseline Quality of Life at 5 Weeks
Time frame: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Change from Baseline Perceived Stress at 5 Weeks
Time frame: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Change from Baseline Mental Wellbeing at 5 Weeks
Time frame: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Brain Tumour Foundation of Canada 2015Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Steven Selchen, MD MSt FRCPC principal investigator
Sunnybrook Health Sciences Centre
Janet Ellis, MB MD FRCPC principal investigator
Sunnybrook Health Sciences Centre
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-based Therapy in people with Brain Tumour and Depressive Symptoms, run by Sunnybrook Health Sciences Centre 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 3 inclusion and 6 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 7 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Depressive Symptoms at 5 Weeks (time frame: Pre- (Week 0) and Post-Treatment Assessment (Week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2019.