Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02792608
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2016-05-26
Brief Title:
Mindfulness-Based Therapy for Brain Tumour Survivors
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Mindfulness-Based Intervention to Improve Quality of Life Among Brain Tumour Survivors
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 55000 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 Therapys 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 eg 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 Therapys 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
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 eg 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 Therapys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None