- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02792608
Mindfulness-Based Therapy for Brain Tumour Survivors
A Mindfulness-Based Intervention to Improve Quality of Life Among Brain Tumour Survivors
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Mindfulness-based Therapy
5 week, manual-based group MBI treatment for depression
|
MBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline Depressive Symptoms at 5 Weeks
Časové okno: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
|
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline Quality of Life at 5 Weeks
Časové okno: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Scale used to measure Quality of Life: Quality of Life after Brain Injury (QOLBRI)
|
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
|
Change from Baseline Perceived Stress at 5 Weeks
Časové okno: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Scale used to measure Perceived Stress: Perceived Stress Scale (PSS)
|
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
|
Change from Baseline Mental Wellbeing at 5 Weeks
Časové okno: Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
|
Pre- (Week 0) and Post-Treatment Assessment (Week 5)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Steven Selchen, MD MSt FRCPC, Sunnybrook Health Sciences Centre
- Vrchní vyšetřovatel: Janet Ellis, MB MD FRCPC, Sunnybrook Health Sciences Centre
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 169-2015
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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