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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

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.

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 groups in NCT02792608
Study groupRoleWhat they receive
Mindfulness-based TherapyExperimental5 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted7 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion23 Nov 2018
  4. Study completion23 Nov 2018

Resources

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)
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

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.

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