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基于网络的老年癌症患者问题提示清单评估和管理工具(MAPLE)用于沟通与老龄化相关问题的研究方案:多中心、平行组、随机对照试验 J-SUPPORT 2101 研究方案。

Geriatric assessment and management with question prompt list using a web-based application for elderly patients with cancer (MAPLE) to communicate ageing-related concerns: J-SUPPORT 2101 study protocol for a multicentre, parallel group, randomised controlled trial.

机构信息

Division of Supportive Care, Survivorship and Translational Research, Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan.

Division of Supportive Care, Survivorship and Translational Research, Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan

出版信息

BMJ Open. 2022 Sep 26;12(9):e063445. doi: 10.1136/bmjopen-2022-063445.

Abstract

INTRODUCTION

Elderly cancer patients often have ageing-related physical and psychosocial problems that should be fully shared with their oncologists. Geriatric assessment (GA) can assess these ageing-related problems and guide management. Communication support might also facilitate implementation of GA-guided management. We will conduct a multicentre, randomised controlled trial to examine the efficacy of a programme that combines a GA summary, management recommendations and communication support to facilitate ageing-related communications between elderly Japanese patients with cancer and their oncologists, and thus to implement programme-guided management.

METHODS AND ANALYSIS

We plan to recruit a total of 210 patients aged ≥70 years, diagnosed with incurable cancers of gastrointestinal origin, and referred for first-line or second-line chemotherapy. In the intervention arm, a summary of management recommendations based on a GA and question prompt list (QPL) will be provided to patients and shared with their oncologists at the first outpatient visit after randomisation by trained intervention providers. For 5 months after the initial intervention, implementation of GA-guided management recommendations will be reviewed monthly with the patients and their oncologists to implement management as needed. The GA and QPL will be re-evaluated at 3 months, with a summary provided to patients and their oncologists. Those participants allocated to the usual care arm will receive usual oncology care. The primary endpoint is the number of conversations about ageing-related concerns at the first outpatient visit after randomisation.

ETHICS AND DISSEMINATION

This study was approved by the institutional review board of the National Cancer Center Japan on 15 April 2021 (ID: 2020-592). Study findings will be disseminated through peer-reviewed journals and conference presentations.

TRIAL REGISTRATION NUMBER

UMIN000045428.

摘要

简介

老年癌症患者常有与衰老相关的身体和心理社会问题,这些问题都应充分与肿瘤医生分享。老年综合评估(GA)可评估这些与衰老相关的问题,并指导管理。沟通支持也可能有助于实施 GA 指导的管理。我们将开展一项多中心、随机对照试验,以检验一种方案的疗效,该方案将 GA 总结、管理建议和沟通支持相结合,以促进日本老年癌症患者及其肿瘤医生之间与衰老相关的沟通,从而实施方案指导的管理。

方法和分析

我们计划招募总共 210 名年龄≥70 岁、诊断为不可治愈的胃肠道来源癌症、并接受一线或二线化疗的患者。在干预组中,在随机分组后的首次门诊就诊时,将根据 GA 和问题提示清单(QPL)为患者提供管理建议摘要,并由经过培训的干预提供者与他们的肿瘤医生共享。在初始干预后的 5 个月内,将每月与患者及其肿瘤医生一起审查 GA 指导的管理建议的实施情况,以根据需要实施管理。将在 3 个月时重新评估 GA 和 QPL,并向患者及其肿瘤医生提供摘要。那些被分配到常规护理组的参与者将接受常规肿瘤护理。主要终点是随机分组后首次门诊就诊时讨论与衰老相关问题的次数。

伦理和传播

这项研究于 2021 年 4 月 15 日获得日本国家癌症中心机构审查委员会的批准(ID:2020-592)。研究结果将通过同行评议的期刊和会议报告进行传播。

试验注册号

UMIN000045428。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dca1/9516071/5f206790fdeb/bmjopen-2022-063445f01.jpg

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