Jefford Michael, Emery Jon, Grunfeld Eva, Martin Andrew, Rodger Paula, Murray Alexandra M, De Abreu Lourenco Richard, Heriot Alexander, Phipps-Nelson Jo, Guccione Lisa, King Dorothy, Lisy Karolina, Tebbutt Niall, Burgess Adele, Faragher Ian, Woods Rodney, Schofield Penelope
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Sir Peter MacCallum Department of Oncology, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia.
Trials. 2017 Oct 30;18(1):506. doi: 10.1186/s13063-017-2245-4.
Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient's primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency.
METHODS/DESIGN: SCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs.
The evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors.
Australian New Zealand Clinical Trials Registry, ACTRN12617000004369p . Registered on 3 January 2017; protocol version 4 approved 24 February 2017.
结直肠癌（CRC）是影响男性和女性的最常见癌症。CRC幸存者常常经历由CRC及其治疗引发的各种身体和心理影响。这些影响可能持续多年并对生活质量产生不利影响，而且基于专科医生的标准随访可能无法充分解决这些问题。对这些影响的最佳管理应利用初级保健和专科保健的专业知识。共享护理模式（涉及患者的初级保健医生[PCP]和专科医生）有潜力更好地支持幸存者并提高卫生系统效率。
方法/设计：SCORE（结直肠癌幸存者共享护理）是一项多中心随机对照试验，旨在优化并实施针对CRC幸存者的共享护理模式，评估干预措施和研究过程的可接受性，并收集有关共享护理与常规护理相比对一系列患者报告结局影响的初步数据。主要结局是使用欧洲癌症研究与治疗组织QLQ-C30问卷测量的生活质量。次要结局包括对护理的满意度、未满足的需求、护理连续性和卫生资源使用情况。共享护理模式包括用PCP就诊取代两次常规专科随访就诊，以及为CRC幸存者提供量身定制的生存护理计划、一本生存手册和一张DVD。所有同意参与的患者将按1:1随机分配至共享护理组或常规护理组，并在12个月内的三个时间点（基线、6个月和12个月）完成问卷调查。还将收集卫生保健资源使用数据并用于评估成本。
评估和实施能够响应癌症幸存者整体需求同时减轻急症护理负担的护理模式是一项国际优先事项。专科医生和PCP之间的共享护理有潜力改善CRC幸存者的患者护理和结局，同时提高卫生保健资源效率。如果本研究结果表明共享护理干预措施对CRC幸存者是可接受且可行的，那么该干预措施可能很容易扩展到其他癌症幸存者群体。
澳大利亚新西兰临床试验注册中心，ACTRN12617000004369p。于2017年1月3日注册；2017年2月24日批准方案版本4。
