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英国乳腺癌随访后的改善（BETTER-CARE）项目：一项集群随机对照复杂干预试验的设计和可行性研究结果。

The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.

机构信息

Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg, Würzburg, Germany.

Department of Gynecology and Obstetrics, University Hospital Würzburg, Würzburg, Germany.

出版信息

Trials. 2024 Nov 14;25(1):767. doi: 10.1186/s13063-024-08614-8.

DOI:10.1186/s13063-024-08614-8
PMID:39543763
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11566082/
Abstract

BACKGROUND

The risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany.

METHODS

We describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence.

RESULTS

The 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach.

DISCUSSION

BETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care.

TRIAL REGISTRATION

German Clinical Trial Register DRKS00028840. Registered on April 2022.

摘要

背景

乳腺癌患者长期治疗副作用（如神经毒性和心脏毒性）和合并症相关晚期效应的风险因人而异。德国常规护理中缺乏针对个体需求和复发风险、副作用和晚期效应的个性化随访护理理念。

方法

我们描述了 BETTER-CARE 的方法学，这是一项在 15 个干预和 15 个对照中心进行的平行臂集群随机对照试验，旨在招募 1140 名患者，并介绍了试验的预试验阶段结果。该基于现有开发框架的需求和风险适应性综合干预措施包括一个多学科网络和数字平台，用于症状和需求文档记录以及即时适应性干预。对照组为根据临床指南提供的常规护理。主要结局为健康相关生活质量（EORTC QLQ-C30 全球健康），次要结局包括治疗依从性。

结果

在一个干预和一个对照预试验中心进行的为期 2 个月的预试验阶段纳入了 16 例患者，证明了 BETTER-CARE 方法的可行性。

讨论

BETTER-CARE 是一种可行的干预和研究理念，在德国调查了个体化需求和风险适应性的乳腺癌随访护理。如果成功，该方法可以在德国常规护理中实施。

试验注册

德国临床试验注册中心 DRKS00028840。2022 年 4 月注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/c4224447133f/13063_2024_8614_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/b9a189c8d009/13063_2024_8614_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/6f0e5a8f7509/13063_2024_8614_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/c4224447133f/13063_2024_8614_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/b9a189c8d009/13063_2024_8614_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/6f0e5a8f7509/13063_2024_8614_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2632/11566082/c4224447133f/13063_2024_8614_Fig3_HTML.jpg

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