Department of Psychology, Mater Misericordiae University Hospital, Dublin, Ireland.
Department of Psycho-Oncology, Mater Misericordiae University Hospital, Dublin, Ireland.
Trials. 2023 Feb 6;24(1):89. doi: 10.1186/s13063-023-07088-4.
A cancer diagnosis is a known precipitant of psychological distress, with fear of recurrence being a well-documented distressing consequence of cancer. Cancer recurrence often results in an additional psychological burden, which may exacerbate as a result of the COVID-19 pandemic.
This is a single-centre, prospective, randomised controlled trial. Patients identified as having experienced cancer recurrence since March 2020 (the onset of the COVID-19 pandemic in Ireland) will be screened for participation. Eligible, consenting candidates who score 4 or higher on the Distress Thermometer will be enrolled in the study. Participants will be randomly allocated to receive either a 6-week, group-based, online, compassion-focussed therapy and breathing pattern retraining intervention or the control arm. Those in the control arm will all be offered the group intervention after the 18-week study period. The primary outcome is the Distress Thermometer score at 18 weeks post-baseline though secondary outcomes will include measures of mood, traumatic distress and mental adjustment to cancer.
To our knowledge, this protocol describes the first RCT which directly examines the effect of a group-based psychological intervention on Irish patients experiencing cancer recurrence in the context of COVID-19. The outcome of this trial is likely to be twofold: It will determine if the psychological intervention achieves its primary objective of distress amelioration 3 months post-intervention and to establish the feasibility of delivering this intervention in a virtual format.
ClinicalTrials.gov NCT05518591. Registered on 25 August 2022. All items from the World Health Organization Trial Registration Data set have been included.
癌症诊断已知会引发心理困扰，对癌症复发的恐惧是癌症患者的一种常见的痛苦后果。癌症复发通常会带来额外的心理负担，而这种负担可能会因 COVID-19 大流行而加剧。
这是一项单中心、前瞻性、随机对照试验。将筛选自 2020 年 3 月（爱尔兰 COVID-19 大流行开始）以来被诊断为癌症复发的患者参加研究。对得分在 4 分或以上的有资格、同意参加的患者进行研究登记。参与者将被随机分配到接受为期 6 周的、基于团体的、在线的、以同情心为重点的治疗和呼吸模式再训练干预组或对照组。对照组的所有参与者将在 18 周的研究期间结束后提供团体干预。主要结局是在基线后 18 周的痛苦温度计评分，但次要结局将包括情绪、创伤性困扰和癌症心理适应的衡量标准。
据我们所知，该方案描述了第一项直接检查基于团体的心理干预对在 COVID-19 背景下经历癌症复发的爱尔兰患者的影响的 RCT。该试验的结果可能有两个方面：它将确定心理干预是否能在干预后 3 个月达到缓解痛苦的主要目标，并确定在虚拟格式下提供这种干预的可行性。
ClinicalTrials.gov NCT05518591。于 2022 年 8 月 25 日注册。包含世界卫生组织试验注册数据集中的所有项目。
