Université Claude Bernard Lyon 1, Université Gustave Eiffel, UMRESTTE UMR T9405, 8 Avenue Rockefeller, Lyon, France.
Hospices Civils de Lyon, Service de Médecine et Santé au Travail, Pôle de Santé Publique, Lyon, France.
BMC Cancer. 2024 Sep 5;24(1):1107. doi: 10.1186/s12885-024-12796-4.
Women with breast cancer face many barriers to return to work (RTW) after their cancer. The main objective of the FASTRACS-RCT is to evaluate the impact of the FASTRACS (Facilitate and Sustain Return to Work after Breast Cancer) intervention on the sustainable RTW of breast cancer patients, 12 months after the end of active treatment.
FASTRACS-RCT is a prospective, national, multicentre, randomized, controlled and open-label study. A total of 420 patients with early breast cancer scheduled for surgery and (neo)adjuvant chemotherapy, will be randomly assigned (1:1 ratio) to: (i) the intervention arm comprising four steps over 6 months : Handing over the intervention tools; transitional medical consultation with the general practitioner (GP); pre-RTW visit with the company's occupational physician (OP); catch-up visit with a hospital-based RTW expert (if sick leave > 10 months) (ii) the control arm to receive usual care. The design of the FASTRACS intervention was informed by intervention mapping for complex interventions in health promotion planning, and involved patients and representatives of relevant stakeholders. Specific tools were developed to bridge the gap between the hospital, the GP, the OP and the workplace: a toolkit for breast cancer patients comprising a theory-based guide; specific checklists for the GP and the OP, respectively; and a theory-based guide for workplace actors (employer, manager, colleagues). The primary endpoint will associate sustainable RTW (full-time or part-time work at 50% or more of working time, for at least 28 consecutive days) and days off work. It will be assessed at 4, 8 and 12 months after the end of active oncological treatment. Secondary endpoints will include quality of life, anxiety, depression, RTW self-efficacy, physical activity, social support, job accommodations, work productivity, job status, and the usefulness and acceptability of the intervention's tools.
FASTRACS-RCT will be supplemented by a realist evaluation approach aimed at understanding the influence of context in activating the intervention's mechanisms and effects. If the expected impact of the intervention is confirmed, the intervention will be adapted and scaled-up for other cancers and chronic diseases to better integrate healthcare and work disability prevention.
NCT04846972 ; April 15, 2021.
患有乳腺癌的女性在癌症治疗后重返工作岗位（RTW）面临诸多障碍。FASTRACS-RCT 的主要目的是评估 FASTRACS（促进和维持乳腺癌患者康复后的重返工作岗位）干预措施对乳腺癌患者的可持续 RTW 的影响，这是在积极治疗结束后 12 个月进行的。
FASTRACS-RCT 是一项前瞻性、全国性、多中心、随机、对照和开放标签研究。共有 420 名计划接受手术和（新）辅助化疗的早期乳腺癌患者，将被随机分配（1:1 比例）到：（i）干预组包括 6 个月内的四个步骤：提供干预工具；与全科医生（GP）进行过渡性医疗咨询；与公司的职业医生（OP）进行预 RTW 访问；如果病假超过 10 个月，与医院的 RTW 专家进行追访（ii）对照组接受常规护理。FASTRACS 干预措施的设计是基于健康促进规划中的复杂干预措施的干预映射，并涉及患者和相关利益相关者的代表。为了弥合医院、全科医生、职业医生和工作场所之间的差距，开发了特定的工具：一个包含基于理论的指南的乳腺癌患者工具包；分别为全科医生和职业医生制定的特定检查表；以及基于理论的工作场所行为者（雇主、经理、同事）指南。主要终点将与可持续 RTW（全职或兼职工作，工作时间达到 50%或更多，至少连续 28 天）和休假天数相关联。它将在积极的肿瘤治疗结束后 4、8 和 12 个月进行评估。次要终点将包括生活质量、焦虑、抑郁、RTW 自我效能感、身体活动、社会支持、工作适应、工作生产力、工作状态以及干预工具的有用性和可接受性。
FASTRACS-RCT 将补充采用现实评估方法，旨在了解背景对激活干预措施的机制和效果的影响。如果干预措施的预期效果得到确认，将对干预措施进行调整和扩展，以用于其他癌症和慢性疾病，以更好地整合医疗保健和工作残疾预防。
NCT04846972；2021 年 4 月 15 日。
