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患者主导的结直肠癌术后家庭随访:前瞻性、多中心 FUTURE-初步实施研究方案。

Patient-led home-based follow-up after surgery for colorectal cancer: the protocol of the prospective, multicentre FUTURE-primary implementation study.

机构信息

Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC, Rotterdam, The Netherlands.

Department of Surgery, Amphia Hospital, Breda, The Netherlands.

出版信息

BMJ Open. 2023 Oct 12;13(10):e074089. doi: 10.1136/bmjopen-2023-074089.

DOI:10.1136/bmjopen-2023-074089
PMID:37827744
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10582858/
Abstract

INTRODUCTION

Colorectal cancer (CRC) is the third most common type of cancer in the Netherlands. Approximately 90% of patients can be treated with surgery, which is considered potentially curative. Postoperative surveillance during the first 5 years after surgery pursues to detect metastases in an early, asymptomatic and treatable stage. Multiple large randomised controlled trials have failed to show any (cancer-specific) survival benefit of intensive postoperative surveillance compared with a minimalistic approach in patients with CRC. This raises the question whether an (intensive) in-hospital postoperative surveillance strategy is still warranted from both a patient well-being and societal perspective. A more modern, home-based surveillance strategy could be beneficial in terms of patients' quality of life and healthcare costs.

METHODS AND ANALYSIS

The multicentre, prospective FUTURE-primary study implements a patient-led home-based surveillance after curative CRC treatment. Here, patients are involved in the choice regarding three fundamental aspects of their postoperative surveillance. First regarding frequency, patients can opt for additional follow-up moments to the minimal requirement as outlined by the current Dutch national guidelines. Second regarding the setting, both in-hospital or predominantly home-based options are available. And third, concerning patient-doctor communication choices ranging from in-person to video chat, and even silent check-ups. The aim of the FUTURE-primary study is to evaluate if such a patient-led home-based follow-up approach is successful in terms of quality of life, satisfaction and anxiety compared with historic data. A successful implementation of the patient-led aspect will be assessed by the degree in which the additional, optional follow-up moments are actually utilised. Secondary objectives are to evaluate quality of life, anxiety, fear of cancer recurrence and cost-effectiveness.

ETHICS AND DISSEMINATION

Ethical approval was given by the Medical Ethics Review Committee of Erasmus Medical Centre, The Netherlands (2021-0499). Results will be presented in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT05656326.

摘要

介绍

结直肠癌(CRC)是荷兰第三大常见癌症类型。大约 90%的患者可以通过手术治疗,该方法被认为具有潜在的治愈性。手术后的 5 年内进行的术后监测旨在早期、无症状和可治疗阶段检测转移。多项大型随机对照试验未能显示出与 CRC 患者的最低限度方法相比,强化术后监测具有任何(癌症特异性)生存获益。这就提出了一个问题,即从患者的健康和社会效益的角度来看,(强化)住院术后监测策略是否仍然是必要的。一种更现代的基于家庭的监测策略可能会提高患者的生活质量并降低医疗成本。

方法和分析

多中心前瞻性 FUTURE-primary 研究实施了一种基于患者的家庭式结直肠癌治疗后监测策略。在这里,患者可以参与到他们术后监测的三个基本方面的决策中。首先是监测频率,患者可以选择在当前荷兰国家指南规定的最低要求之外增加随访次数。其次是监测场所,患者可以选择在医院或主要在家庭进行监测。最后是医患沟通方式,包括面对面、视频聊天,甚至是无声的检查。FUTURE-primary 研究的目的是评估基于患者的家庭式随访方法在生活质量、满意度和焦虑方面是否成功,与历史数据相比。通过实际利用额外的可选随访次数的程度来评估患者主导方面的成功实施情况。次要目标是评估生活质量、焦虑、对癌症复发的恐惧和成本效益。

伦理和传播

荷兰伊拉斯谟医疗中心医学伦理审查委员会批准了该研究(2021-0499)。研究结果将在同行评议的期刊上发表。

试验注册号

NCT05656326。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/a78f55ede79f/bmjopen-2023-074089f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/8c23948e70c4/bmjopen-2023-074089f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/72071e375d8b/bmjopen-2023-074089f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/a78f55ede79f/bmjopen-2023-074089f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/8c23948e70c4/bmjopen-2023-074089f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/72071e375d8b/bmjopen-2023-074089f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd8a/10582858/a78f55ede79f/bmjopen-2023-074089f03.jpg

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