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一项临床医生干预措施减少癌症幸存者复发恐惧的实施研究方案(CIFeR_2 实施研究)。

Protocol of an implementation study of a clinician intervention to reduce fear of recurrence in cancer survivors (CIFeR_2 implementation study).

机构信息

Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, NSW, Australia.

School of Psychology, Psycho-Oncology Cooperative Research Group, The University of Sydney, Sydney, NSW, Australia.

出版信息

BMC Med Educ. 2023 May 5;23(1):312. doi: 10.1186/s12909-023-04279-0.

Abstract

BACKGROUND

Fear of cancer recurrence (FCR) affects 50-70% of cancer survivors with 30% reporting an unmet need for help with managing FCR. Patients indicate desire to discuss FCR with clinicians, however clinicians indicate discomfort with managing FCR and no formal educational interventions on how to discuss FCR or worry exists for oncology clinicians. Our team developed a novel clinician-driven brief education intervention to help patients manage FCR (the Clinician Intervention to Reduce Fear of Recurrence (CIFeR) intervention). In earlier work, we demonstrated the feasibility, acceptability, and efficacy of CIFeR in reducing FCR in breast cancer patients. We now aim to explore the barriers and facilitators to implementing this low-cost brief intervention within routine oncology practice in Australia. The primary objective is to assess the adoption of CIFeR in routine clinical practice. Secondary objectives are to identify the uptake and sustainability, perceived acceptability, feasibility, costs, barriers and facilitators of implementation of CIFeR in routine clinical practice, and to assess whether training in CIFeR increases clinicians' self-efficacy in managing FCR with their patients.

METHODS

This multicentre, single-arm Phase I/II implementation study will recruit medical and radiation oncologists and oncology surgeons who treat women with early breast cancer. Participants will complete online CIFeR training. They will then be asked to use CIFeR with suitable patients for the next 6 months. Participants will complete questionnaires prior to, immediately after and 3 and 6 months after training to assess confidence addressing FCR, and 3 and 6 months after training to assess Proctor Implementation outcomes. At 6 months, they will also be asked to participate in a semi-structured telephone interview to elicit their feedback about barriers and facilitators to using CIFeR in routine clinical practice.

DISCUSSION

This study will provide further data to support the routine use of an evidence-based, clinician-lead educational intervention to reduce FCR in breast cancer patients. Additionally, this study will identify any barriers and facilitators to implementing the CIFeR intervention in routine care and evidence for integration of FCR training into oncology communication skills education.

TRIAL REGISTRATION

Prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12621001697875.

TRIAL SPONSOR

Chris O'Brien Lifehouse.

PROTOCOL VERSION

2.6, Dated 28th February 2023.

摘要

背景

癌症复发恐惧(FCR)影响了 50-70%的癌症幸存者,其中 30%的人表示在管理 FCR 方面存在未满足的需求。患者表示希望与临床医生讨论 FCR,但临床医生表示在管理 FCR 方面感到不适,并且没有关于如何讨论 FCR 或担心肿瘤学临床医生的正式教育干预措施。我们的团队开发了一种新的临床医生驱动的简短教育干预措施,以帮助患者管理 FCR(临床医生干预以减少复发恐惧(CIFeR)干预)。在早期工作中,我们证明了 CIFeR 在减少乳腺癌患者 FCR 方面的可行性、可接受性和有效性。现在,我们旨在探索在澳大利亚常规肿瘤学实践中实施这种低成本简短干预措施的障碍和促进因素。主要目标是评估 CIFeR 在常规临床实践中的采用情况。次要目标是确定 CIFeR 在常规临床实践中的采用情况、可持续性、可接受性、可行性、成本、障碍和促进因素,以及评估 CIFeR 培训是否会增加临床医生在管理患者 FCR 方面的自我效能感。

方法

这项多中心、单臂 I/II 期实施研究将招募治疗早期乳腺癌的医学和放射肿瘤学家以及肿瘤外科医生。参与者将完成在线 CIFeR 培训。然后,他们将被要求在接下来的 6 个月内使用 CIFeR 为合适的患者服务。参与者将在培训前、培训后立即以及培训后 3 个月和 6 个月完成问卷,以评估他们在处理 FCR 方面的信心,并在培训后 3 个月和 6 个月评估 Proctor 实施结果。6 个月时,他们还将被要求参加半结构化电话访谈,以了解他们在常规临床实践中使用 CIFeR 的障碍和促进因素的反馈。

讨论

这项研究将提供进一步的数据,以支持常规使用基于证据的、由临床医生主导的教育干预措施来降低乳腺癌患者的 FCR。此外,这项研究将确定在常规护理中实施 CIFeR 干预措施的任何障碍和促进因素,并为将 FCR 培训纳入肿瘤学沟通技巧教育提供证据。

试验注册

前瞻性注册于澳大利亚和新西兰临床试验注册处,ACTRN12621001697875。

试验赞助商

Chris O'Brien 生命屋。

协议版本

2.6,日期为 2023 年 2 月 28 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8918/10161640/4ba409785e06/12909_2023_4279_Fig1_HTML.jpg

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