Department of Nursing and Integrated Health Sciences, Faculty of Health Sciences, Kristianstad University, Kristianstad, Sweden.
Department of Clinical Sciences Lund, Surgery, Lund University, Skåne University Hospital, Lund, Sweden.
BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3.
It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment.
The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ≥5 are randomized to the intervention or control group while patients scoring ≤4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2 weeks and 3, 6, 9 and 12 months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated.
This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice.
ClinicalTrials.gov NCT03434717. Registered February 15, 2018.
众所周知，女性在接受乳腺癌（BC）治疗后会遭受负面后果，而且她们对康复的需求差异很大，往往无法得到满足。多达 43%的女性有发展为需要复杂干预的慢性困扰的风险；然而，如何及早识别和满足这些女性的需求尚不清楚，这使得她们的康复机会不理想。ReScreen 研究的目的是开发一种基于筛查的个体化康复模式，并评估其在原发性 BC 治疗后的效果。
ReScreen 研究设计为一项复杂的干预研究。连续纳入新诊断为 BC 的女性患者进行三臂随机对照试验。在纳入时，患者使用 Distress Thermometer（0-10 分）评分，旨在识别有扩展康复需求的患者。评分≥5 的患者随机分为干预组或对照组，而评分≤4 的患者作为观察组进行纵向随访。干预组患者与专门的研究护士一起，根据证据支持的决策支持工具制定个体化康复计划，为干预提供坚实的基础。研究护士将作为连续的医疗保健联系人，负责主动和系统地评估患者的需求，以确保在 1 年的随访期间识别出潜在的新问题或改变的康复需求。通过自我报告的数据评估干预效果，重点关注身体和心理结果，以及基线、2 周、3、6、9 和 12 个月时对护理的满意度评估。评估还将包括基于登记数据和患者及家属对康复过程的经验的健康经济学方面。此外，还将研究痛苦作为扩展康复需求指标的最佳截断值。
这项研究将提供与基于筛查的康复需求识别和原发性 BC 治疗后标准化基于证据的个体化康复的有效性相关的重要知识。通过复杂的干预设计，该研究有可能形成一个全面的知识库，其中包括工具和指南，以将其纳入临床实践。
ClinicalTrials.gov NCT03434717。注册于 2018 年 2 月 15 日。
