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.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-01-30 DOI:10.1186/s13063-025-08734-9
Clare Robinson, Trudie Chalder, Paul McCrone, Olivier Quintin, Evdoxia Gkaintatzi, Imran Khan, Stephanie J C Taylor
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引用次数: 0

Abstract

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.

一项实用的随机对照试验的统计分析计划,比较癌症患者或超越癌症的患者接受和承诺治疗加(+)常规善后护理与仅常规善后护理:癌症后幸存者康复评估(SURECAN)试验。
背景:SURECAN试验的目的是评估基于接受和承诺疗法(ACT Plus(+))的以人为本的干预措施,该干预措施适用于已完成癌症治疗但生活质量较差的患者。我们提出了统计分析计划,以评估随机化后1年干预措施在改善生活质量方面的有效性和成本效益。方法和设计:SURECAN是一项多中心、实用、双组、部分聚类、随机对照的优势试验,比较ACT +加在常规护理和常规护理后的有效性。目标样本量为344例(每组172例),按1:1的比例随机分配。结果:主要结果是52周时癌症治疗功能评估量表-一般(FACT-G)的总分,使用带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周时的评分:FACT-G量表;癌症复发恐惧量表;癌症量表(IOCv2)的正面和负面影响;医院焦虑抑郁量表;Chalder疲劳量表(CFQ);和身体活动,用改良版的戈丁量表来测量。健康经济分析将根据质量调整生命年(QALYs)确定增量成本-效果比(ICER),该质量调整生命年(QALYs)来源于Euroqol 5维5水平(EQ-5D-5L),与常规护理相比为52周。讨论:本文是SURECAN试验的统计分析计划(SAP)和经济评价。任何探索性或事后分析都将在各自的分析报告中确定。试验注册:试验前瞻性注册。Isrctn: ISRCTN67900293。2019年12月9日注册
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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