Sarcoma Unit, Royal Marsden Hospital NHS Trust, London, UK.
Medical Oncology, Radboudumc, Nijmegen, Gelderland, The Netherlands.
BMJ Open. 2020 Jun 1;10(6):e035171. doi: 10.1136/bmjopen-2019-035171.
Chemotherapy is the mainstay of treatment for patients with advanced soft tissue sarcomas (STS). Treatment intent is usually palliative, aiming to improve symptoms, stabilise or reduce tumour burden and extend life. Clinical trials have traditionally used radiological response, time to progression and survival as measures of treatment efficacy. Health-related quality of life (HRQoL) is at least equally important or more important than survival for many patients with advanced cancer. Systematically collecting HRQoL data during chemotherapy can provide greater insight into treatment efficacy from the patient perspective.The primary aims of this study are to evaluate HRQoL in patients with advanced STS treated with chemotherapy over time, explore the decision-making process and patient reflection post-treatment.
This is an observational, international cohort study for 132 patients aged ≥18 years with advanced STS treated at eight centres (three in the UK, five in the Netherlands). Patients will be recruited prior to starting first-line or third-line chemotherapy and invited to complete questionnaires using the Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship registry (PROFILES); an established international registry for collection of cancer patient-reported outcomes. Online (or paper) questionnaires will be completed at baseline, each cycle of chemotherapy and 2-3 monthly during follow-up. The questionnaire package includes the Decisional Conflict Scale, Control Preferences Scale, Quality-Quantity Questionnaire, treatment expectations, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), EORTC financial toxicity items, Work Ability Index, Functional Assessment of Cancer Therapy-General (FACT-G) items and Decisional Regret Scale. Clinical data will be extracted from patient records and linked with questionnaire responses. The primary outcome measure is the change in global HRQoL from baseline to after cycle 4 of first-line chemotherapy (based on published data showing that patients with advanced STS complete a median number of four cycles of first-line chemotherapy).
Heath Research Authority and Research Ethics Committee (REC 17/NI/0197). Results from the Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy (HOLISTIC) study will be published in peer-reviewed journals and disseminated at local, national and international conferences. We will also present our findings at any appropriate patient meetings and involve patients in study-related publications.
NCT03621332.
化疗是治疗晚期软组织肉瘤（STS）患者的主要方法。治疗目的通常是姑息性的，旨在改善症状、稳定或减轻肿瘤负担并延长生命。临床试验传统上使用影像学反应、无进展时间和生存作为治疗效果的衡量标准。对于许多晚期癌症患者来说，健康相关生活质量（HRQoL）至少与生存同等重要，甚至更为重要。在化疗过程中系统地收集 HRQoL 数据可以从患者角度提供更深入的治疗效果见解。本研究的主要目的是随着时间的推移评估接受化疗的晚期 STS 患者的 HRQoL，探索治疗后患者的决策过程和反思。
这是一项针对在 8 个中心（英国 3 个，荷兰 5 个）接受治疗的 132 名年龄≥18 岁的晚期 STS 患者的观察性国际队列研究。患者将在开始一线或三线化疗前招募，并邀请他们使用初始治疗和生存长期评估后的患者报告结果登记册（PROFILES）完成问卷；这是一个用于收集癌症患者报告结果的成熟国际登记处。在线（或纸质）问卷将在基线、每个化疗周期以及随访期间每 2-3 个月完成。问卷包包括决策冲突量表、控制偏好量表、质量-数量问卷、治疗期望、欧洲癌症研究与治疗组织生活质量问卷核心 30 版（EORTC-QLQ-C30）、EORTC 财务毒性项目、工作能力指数、癌症治疗功能评估一般量表（FACT-G）项目和决策后悔量表。临床数据将从患者记录中提取，并与问卷回答相关联。主要结局指标是从基线到一线化疗第 4 周期后全球 HRQoL 的变化（基于发表的数据表明，晚期 STS 患者完成中位数为 4 个周期的一线化疗）。
英国卫生保健与创新署和研究伦理委员会（REC 17/NI/0197）。来自化疗治疗晚期软组织肉瘤患者健康相关生活质量的研究（HOLISTIC）的结果将发表在同行评议期刊上，并在地方、国家和国际会议上传播。我们还将在任何适当的患者会议上介绍我们的发现，并让患者参与研究相关的出版物。
NCT03621332。
