Mindfulness-Based Therapy for Brain Tumour Survivors

NCT02792608 | Completed

• 1 other identifier: 169-2015
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumour; Depressive Symptoms; Survivors

Keywords

Mindfulness-based Therapy; Brain Tumour Survivors; Depressive Symptoms; Quality of Life; Perceived Stress; Wellbeing; Treatment

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Depressive Symptoms at 5 Weeks

  Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)

  Pre- (Week 0) and Post-Treatment Assessment (Week 5)

Secondary Outcomes (3)

• Change from Baseline Quality of Life at 5 Weeks

  Pre- (Week 0) and Post-Treatment Assessment (Week 5)

• Change from Baseline Perceived Stress at 5 Weeks

  Pre- (Week 0) and Post-Treatment Assessment (Week 5)

• Change from Baseline Mental Wellbeing at 5 Weeks

  Pre- (Week 0) and Post-Treatment Assessment (Week 5)

Study Arms (1)

Mindfulness-based Therapy

EXPERIMENTAL

5 week, manual-based group MBI treatment for depression

Behavioral: Mindfulness-based Therapy

Interventions

Mindfulness-based Therapy BEHAVIORAL

MBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group.

Mindfulness-based Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consenting brain tumour survivor at The Odette Cancer Centre
• \>six months post-treatment
• Ability to communicate, in written and spoken English

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Brain Tumour Foundation of Canada: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms; Depression

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Steven Selchen, MD MSt FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Janet Ellis, MB MD FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 7, 2016
• Study Start: August 1, 2016
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: June 7, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)