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新辅助放化疗后完全肿瘤缓解患者对随机对照试验的需求、偏好和参与意愿:一项食管癌患者的定性研究。

Needs, preferences, and patient participation for a randomized controlled trial on postneoadjuvant complete tumor response: A qualitative study of patients with esophageal cancer.

机构信息

Department of Psychiatry and Psychotherapy/Division for Interventional Biological Psychiatry, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Endowed Professorship Self-Help Research, Comprehensive Cancer Center, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

出版信息

Support Care Cancer. 2024 Sep 11;32(10):650. doi: 10.1007/s00520-024-08845-0.

DOI:10.1007/s00520-024-08845-0
PMID:39256205
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11387432/
Abstract

PURPOSE

For patients with clinical complete response of non-metastatic esophageal cancer (EC) after neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT), the two treatment options obligate postneoadjuvant surgery as the current standard treatment (surgery on principle) versus active surveillance with surgery as needed only in recurring loco-regional tumor as a possible future alternative or standard exist. Since these treatments are presumably equivalent in terms of overall survival, patient-centered information can encourage the discussion with the treating physician and can make it easier for patients to make trade-offs between the advantages and disadvantages of the treatment alternatives in a highly distressed situation.

METHODS

A qualitative prospective cross-sectional study was conducted to create patient-centered information material that is based on patients' preferences, needs, and concerns regarding the two treatment options, and to investigate the potential participation in a consecutive randomized controlled trial (RCT). Therefore, EC patients (N = 11) were asked about their attitudes.

RESULTS

Concerns about the surgery and possible postoperative impairments in quality of life were identified as most mentioned negative aspects of surgery on principle, and recurrence and progression fear and the concern that surgery cannot be avoided anyways as most named negative aspects of surgery as needed. In regard to the participation in an RCT, making a contribution to science and the hope that the novel therapy would be superior to the established one were relevant arguments to participate. On the other hand, the lack of a proactive selection of treatment was named an important barrier to participation in an RCT.

CONCLUSION

The importance of adapting medical conversations to the patients' lack of expertise and their exceptional cognitive and emotional situation is stressed. Results of this study can be used to improve patient-centered information and the recruitment of patients in RCTs in cancer.

摘要

目的

对于接受新辅助放化疗(nCRT)或新辅助化疗(nCT)后非转移性食管癌(EC)达到临床完全缓解的患者,目前的标准治疗是在新辅助治疗后进行强制性辅助手术(原则上手术),或者仅在局部区域性肿瘤复发时进行主动监测,必要时进行手术,这是一种可能的替代方案或标准。由于这些治疗方法在总生存期方面可能具有等效性,因此以患者为中心的信息可以鼓励与治疗医生进行讨论,并使患者在高度痛苦的情况下更容易在治疗选择的优缺点之间进行权衡。

方法

进行了一项定性前瞻性横断面研究,旨在创建基于患者对两种治疗选择的偏好、需求和关注点的以患者为中心的信息材料,并调查其参与连续随机对照试验(RCT)的可能性。因此,EC 患者(N=11)被问及他们的态度。

结果

对手术的担忧以及术后生活质量可能受损被认为是原则上手术的最主要负面方面,而对复发和进展的恐惧以及对手术无法避免的担忧则是按需手术的最主要负面方面。关于参与 RCT,为科学做出贡献以及希望新疗法优于既定疗法是参与的相关论据。另一方面,缺乏主动选择治疗方法被认为是参与 RCT 的一个重要障碍。

结论

强调了使医学对话适应患者缺乏专业知识以及他们特殊的认知和情感情况的重要性。本研究的结果可用于改进癌症中以患者为中心的信息和 RCT 患者的招募。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39da/11387432/bdae8f26665e/520_2024_8845_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39da/11387432/bdae8f26665e/520_2024_8845_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39da/11387432/bdae8f26665e/520_2024_8845_Fig1_HTML.jpg

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