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Mindfulness-Based Therapy for Brain Tumour Survivors

2019年6月5日 更新者:Sunnybrook Health Sciences Centre

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

23

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4N 3M5
        • Sunnybrook Health Sciences Centre

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline Depressive Symptoms at 5 Weeks
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline Quality of Life at 5 Weeks
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Steven Selchen, MD MSt FRCPC、Sunnybrook Health Sciences Centre
  • 主任研究者:Janet Ellis, MB MD FRCPC、Sunnybrook Health Sciences Centre

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年8月1日

一次修了 (実際)

2018年11月23日

研究の完了 (実際)

2018年11月23日

試験登録日

最初に提出

2016年5月26日

QC基準を満たした最初の提出物

2016年6月2日

最初の投稿 (見積もり)

2016年6月7日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月7日

QC基準を満たした最後の更新が送信されました

2019年6月5日

最終確認日

2018年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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