一项实用随机对照试验的统计分析计划，该试验比较了增强型接纳与承诺疗法加（+）附加到常规后续护理与仅常规后续护理，针对癌症患者或癌症康复者：癌症幸存者康复评估（SURECAN）试验
Statistical analysis plan for a pragmatic randomised controlled trial comparing enhanced acceptance and commitment therapy plus ( +) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN) trial.
作者信息
Robinson Clare, Chalder Trudie, McCrone Paul, Quintin Olivier, Gkaintatzi Evdoxia, Khan Imran, Taylor Stephanie J C
机构信息
Centre for Evaluation and Methods, Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
Institute of Psychiatry, Psychology and Neuroscience, King's College London, De'Crespigny Park, London, UK.
出版信息
Trials. 2025 Jan 30;26(1):32. doi: 10.1186/s13063-025-08734-9.
BACKGROUND
The aim of the SURECAN trial is to evaluate a person-centred intervention, based on Acceptance and Commitment Therapy (ACT Plus ( +)), for people who have completed treatment for cancer with curative intent, but are experiencing poor quality of life. We present the statistical analysis plan for assessing the effectiveness and cost-effectiveness of the intervention in improving quality of life 1 year post randomisation.
METHODS AND DESIGN
SURECAN is a multi-centre, pragmatic, two-arm, partially clustered randomised controlled superiority trial comparing the effectiveness of ACT + added to usual care with usual aftercare. The target sample size is 344 (172 per arm), randomised centrally in a 1:1 ratio.
RESULTS
The primary outcome is the total score of the Functional Assessment of Cancer Therapy scale-General (FACT-G) at 52 weeks, analysed using a partially nested mixed-effects model with heteroskedastic error terms. Secondary outcomes include scores at 16 and 52 weeks: FACT-G subscales; Fear of Cancer Recurrence Inventory (FCR4); positive and negative Impact of Cancer scales (IOCv2); Hospital Anxiety and Depression scale (HADS); Chalder Fatigue Scale (CFQ); and physical activity, measured on a modified version of the Godin scale. Health economic analyses will determine the incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) derived from the Euroqol 5-Dimension 5-Level (EQ-5D-5L) compared to usual care at 52 weeks.
DISCUSSION
This manuscript is the statistical analysis plan (SAP) and economic evaluation for the SURECAN trial. Any exploratory or post hoc analyses will be identified as such in the respective analysis report.
TRIAL REGISTRATION
The trial was prospectively registered.
ISRCTN
ISRCTN67900293. Registered on 09 December 2019.
背景
SURECAN试验的目的是评估一种以患者为中心的干预措施，该措施基于接受与承诺疗法（ACT Plus（+）），针对那些已完成根治性癌症治疗但生活质量较差的患者。我们展示了用于评估随机分组后1年干预措施在改善生活质量方面的有效性和成本效益的统计分析计划。
方法与设计
SURECAN是一项多中心、务实、双臂、部分整群随机对照优势试验，比较在常规后续护理基础上加用ACT+与单纯常规后续护理的有效性。目标样本量为344例（每组172例），以1:1的比例进行中心随机分组。
结果
主要结局是52周时癌症治疗功能评估量表-通用版（FACT-G）的总分，使用具有异方差误差项的部分嵌套混合效应模型进行分析。次要结局包括16周和52周时的得分：FACT-G子量表；癌症复发恐惧量表（FCR4）；癌症的正负影响量表（IOCv2）；医院焦虑抑郁量表（HADS）；查尔德疲劳量表（CFQ）；以及通过改良版戈丁量表测量的身体活动。卫生经济分析将确定与52周时的常规护理相比，从欧洲五维度五水平健康量表（EQ-5D-5L）得出的质量调整生命年（QALY）方面的增量成本效益比（ICER）。
讨论
本手稿是SURECAN试验的统计分析计划（SAP）和经济评估。任何探索性或事后分析将在各自的分析报告中明确说明。
试验注册
该试验已进行前瞻性注册。
国际标准随机对照试验编号
ISRCTN67900293。于2019年12月9日注册。
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