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多学科协作型癌症支持团队对胃肠道肿瘤化疗的临床疗效评估:M-CAST 研究的前瞻性观察研究方案。

Evaluation of clinical effects of a multidisciplinary-collaborated cancer support team for gastrointestinal cancer chemotherapy: prospective observational study protocol of M-CAST study.

机构信息

Department of Pharmacy, The IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-Ku, Tokyo, 108-8639, Japan.

Department of Nursing, The IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-Ku, Tokyo, 108-8639, Japan.

出版信息

BMC Gastroenterol. 2023 Jun 19;23(1):215. doi: 10.1186/s12876-023-02849-6.

DOI:10.1186/s12876-023-02849-6
PMID:37337152
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10280873/
Abstract

BACKGROUND

Although the multidisciplinary-collaborated team approach in cancer treatment has recently become popular, prospectively evaluated evidence is limited. We started a multidisciplinary-collaborated cancer support team (MCST) to facilitate cooperation across multidisciplinary medical staff in our hospital and established clinical evidence of supportive care. This study aimed to prospectively evaluate the clinical activity and effect of MCST in patients with gastrointestinal cancer receiving chemotherapy.

METHODS

This is a single-center, single-arm, observational study. Patients with gastrointestinal cancer scheduled to receive chemotherapy are enrolled and supported by the MCST. The primary endpoints are the number of interventions by medical staff and the number of patients who showed improvement in side effects. The secondary endpoints are the severity of side effects, medical expenses, number of consultations, the acceptance rate of prescription recommendations, adjuvant chemotherapy completion rates, dose intensity, and time required for co-medical intervention. In addition, medical staff and attending physicians evaluate all adverse events.

DISCUSSION

This study is expected to contribute to establishing new cancer-supportive care teams for patients with gastrointestinal cancer receiving chemotherapy and those with cancer receiving chemotherapy.

TRIAL REGISTRATION

This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCT1030220495. The date of first registration, 29/11/2022, https://jrct.niph.go.jp/search.

摘要

背景

尽管癌症治疗中的多学科协作团队方法最近变得流行,但前瞻性评估的证据有限。我们成立了一个多学科协作癌症支持团队(MCST),以促进医院多学科医疗人员之间的合作,并建立支持性护理的临床证据。本研究旨在前瞻性评估 MCST 在接受化疗的胃肠道癌症患者中的临床活动和效果。

方法

这是一项单中心、单臂、观察性研究。计划接受化疗的胃肠道癌症患者被纳入并由 MCST 支持。主要终点是医务人员干预的次数和副作用改善的患者人数。次要终点是副作用的严重程度、医疗费用、咨询次数、处方建议的接受率、辅助化疗完成率、剂量强度以及共同医疗干预所需的时间。此外,医务人员和主治医生评估所有不良事件。

讨论

这项研究有望为接受化疗的胃肠道癌症患者和接受化疗的癌症患者建立新的癌症支持性护理团队做出贡献。

试验注册

这项试验在日本临床试验注册中心(jRCT)注册为 jRCT1030220495。首次注册日期为 2022 年 11 月 29 日,网址为 https://jrct.niph.go.jp/search。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80a6/10280873/2d97012dc20e/12876_2023_2849_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80a6/10280873/37464fda5013/12876_2023_2849_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80a6/10280873/2d97012dc20e/12876_2023_2849_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80a6/10280873/37464fda5013/12876_2023_2849_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80a6/10280873/2d97012dc20e/12876_2023_2849_Fig2_HTML.jpg

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