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临床试验/NCT05518591
NCT05518591Unknown不适用

A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.

University College Dublin1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年3月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Overall Distress Score

研究概览

简要总结

The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.

详细描述

This study plans to study how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the pandemic, having previously been diagnosed with cancer. We know that a cancer diagnosis can often result in significant psychological distress. After or during treatment for cancer, individuals often experience a 'fear of recurrence', which should it occur, often results in a state of mental anguish that is described as being more punishing than the initial diagnosis itself. Being diagnosed with a cancer recurrence diagnosis can trigger marked negative psychological symptoms, including distress, uncertainty, traumatic distress and adjustment problems, with psychological recovery from this diagnosis often being slower than that of the initial cancer diagnosis. The COVID-19 pandemic has affected these patients further, in terms of restricted access to healthcare, reduced social supports, and greater levels of treatment uncertainty. Our research team has designed a psychological intervention that is specifically aimed to help some of these issues. It's a 6-week online group intervention using a 'compassion focused therapy' approach, coupled with specialised breathing techniques to reduce bodily distress. It is being done online due to ongoing concerns around COVID but also to eliminate geographical and/or commuting barriers. It is our expectation that those receiving the psychological intervention will experience noticeable reductions in measures of psychological distress compared to those who are receiving regular treatment. It is our hope that the outcomes of this study will inform how best to help patients facing into cancer recurrence at a national level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18 or older
  • pre-existing cancer diagnosis
  • diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
  • Living in Ireland
  • English speaking / fluency
  • Access to web / tech support

排除标准

  • A score <4 on the Distress Thermometer
  • Patient non-consent
  • The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
  • Known or suspected drug or alcohol abuse problems within past 3 months
  • Inability to follow the study procedures e.g. dementia or non-fluency of English
  • Life expectancy <3 months

结局指标

主要结局

Overall Distress Score

时间窗: 12 weeks post completion of intervention

The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)

次要结局

  • Changes in depressive symptoms(12 weeks post completion of intervention)
  • Changes in traumatic distress(12 weeks post completion of intervention)
  • Mental Adjustment to Cancer Recurrence(12 weeks post completion of intervention)
  • Changes in anxiety symptoms(12 weeks post completion of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donal Brennan

Professor Donal Brennan

University College Dublin

研究点 (1)

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