多模态术前康复方案在一家大型癌症医院接受新辅助治疗的乳腺癌女性中的可行性研究:方案。
Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.
机构信息
Supportive Care and Integrative Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
NICM Health Research Institute, Western Sydney University, Westmead, New South Wales, Australia.
出版信息
BMJ Open. 2024 Mar 20;14(3):e080239. doi: 10.1136/bmjopen-2023-080239.
INTRODUCTION
Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.
METHODS AND ANALYSIS
This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.
ETHICS AND DISSEMINATION
The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.
TRIAL REGISTRATION NUMBER
ACTRN12622000584730.
简介
新辅助治疗已成为 II/III 期 HER2 阳性和三阴性乳腺癌患者以及局部晚期和边界可切除高危、管腔 B 型乳腺癌的选择良好患者的标准治疗方法。新辅助治疗的副作用,如疲劳、心脏毒性、神经毒性、焦虑、失眠、血管舒缩症状、胃肠道紊乱以及一系列免疫相关不良事件,可能会影响治疗耐受性、长期结果和生活质量。在手术前提供早期支持性护理(通常称为“预康复”)可能会减轻这些副作用并提高生活质量。在我们对干预措施进行共同设计的过程中,消费者和医疗保健专业人员表示希望有一个“打包”护理、易于获得且嵌入其护理路径的方案。我们假设,包括运动和补充疗法在内的多模式支持性护理方案,并以行为改变理论为基础,将提高自我效能感、生活质量、手术准备和乳腺癌患者的任何额外治疗效果。我们旨在探讨心血管代谢、残留癌负荷和手术结果,以及化疗完成情况(相对剂量强度)。本文介绍了一项多模式预康复计划的可行性研究方案。
方法和分析
这是一项针对医院环境中 20-30 名接受新辅助治疗的乳腺癌女性的多模式方案的前瞻性、混合方法、可行性研究。主要结局是招募率、保留率、依从性和可接受性。次要结局包括患者报告的结果测量(PROMs)、手术结果、住院时间、对手术的满意度、化疗完成率、代谢标志物的变化和不良事件。访谈和焦点小组以了解预康复的经验以及可能影响干预可行性的不同因素。这项研究的结果将是一个共同设计的、有证据支持的干预措施,由乳腺癌患者和照顾他们的医疗保健专业人员评估其可行性和可接受性。
伦理和传播
该研究获得了圣文森特医院 HREC 的伦理批准(HREC/2021/ETH12198)。试验结果将通过出版物和会议向参与者、医疗保健专业人员和公众传达。
试验注册号
ACTRN12622000584730。