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远程医疗老年评估与支持性护理干预(GAIN-S)项目:一项随机临床试验。

Telehealth Geriatric Assessment and Supportive Care Intervention (GAIN-S) Program: A Randomized Clinical Trial.

作者信息

Bergerot Cristiane Decat, Bergerot Paulo Gustavo, Razavi Marianne, França Marcos Vinicius da Silva, da Silva Jonas Ribeiro Gomes, Cerveira Jose Adolfo, Fuzita William Hiromi, de Azeredo Andressa Cardoso, Dos Anjos Gabriel Marques, de Vasconcellos Vitor Fiorin, Philip Errol J, de Matos Neto João Nunes, Canedo Jorge Fernandes, Laloni Mariana Tosello, Ferreira Carlos Gil Moreira, Buso Marco Murilo, Pal Sumanta K, Nipp Ryan, El-Jawahri Areej, Soto-Perez-de-Celis Enrique, Dale William

机构信息

1Oncoclinicas & Co - Medica Scientia Innovation Research (MEDSIR), Sao Paulo, Brazil.

2Department of Supportive Care Medicine, City of Hope National Medical Center, Duarte, CA.

出版信息

J Natl Compr Canc Netw. 2025 Jun;23(6):219-226. doi: 10.6004/jnccn.2025.7020.

DOI:10.6004/jnccn.2025.7020
PMID:40499588
Abstract

BACKGROUND

Older patients with cancer face challenges in accessing high-quality cancer care, especially in resource-limited settings. We assessed the impact of a telehealth-adapted Geriatric Assessment-Guided Intervention (GAIN-S) among older Brazilians with metastatic cancer.

PATIENT AND METHODS

This randomized clinical trial enrolled adults aged ≥65 years with metastatic cancer between June 2022 and July 2023. Patients were randomly assigned (1:1) to receive either usual care or GAIN-S. In the GAIN-S arm, a multidisciplinary team (MDT) developed an intervention plan based on impairments identified through geriatric assessment (GA). The plan included MDT discussions and targeted referrals to psychiatry, social services, nutrition, supportive care, and certified fitness training over a 3-month period. Assessments were conducted at baseline and at 3 months. The primary outcome was change in physical function, measured by instrumental activities of daily living (IADL) at 3 months. Secondary endpoints included changes in mood (assessed using the Geriatric Depression Scale [GDS]), quality of life (assessed using the Functional Assessment of Cancer Therapy-General [FACT-G]), and prognostic understanding. T tests and linear mixed models were used to compare groups at each timepoint and to assess longitudinal change.

RESULTS

A total of 80 patients were enrolled (40 per arm). Clinical characteristics were well balanced between arms. Most patients were female (55.8%), with a mean age of 74 years (range, 65-88). At 3 months, patients in the GAIN-S arm showed improvements in physical function (IADL, +1.8), mood (GDS, -2.7), quality of life (FACT-G, +13.2), and symptom burden (assessed using the Edmonton Symptom Assessment System [ESAS], -14.6), all with P values <.001. Patients in the intervention group also demonstrated more accurate prognostic understanding (P<.01).

CONCLUSIONS

This study demonstrates the efficacy of the telehealth-administered GAIN-S intervention in older adults with cancer in Brazil. These findings underscore the importance of tailoring GA-guided interventions for resource-limited settings.

摘要

背景

老年癌症患者在获得高质量癌症治疗方面面临挑战,尤其是在资源有限的环境中。我们评估了一种适用于远程医疗的老年评估指导干预措施(GAIN-S)对患有转移性癌症的巴西老年人的影响。

患者与方法

这项随机临床试验纳入了2022年6月至2023年7月期间年龄≥65岁的转移性癌症成人患者。患者被随机分配(1:1)接受常规护理或GAIN-S。在GAIN-S组中,一个多学科团队(MDT)根据通过老年评估(GA)确定的损伤制定了干预计划。该计划包括MDT讨论以及在3个月内针对性地转诊至精神科、社会服务、营养、支持性护理和经认证的健身训练。在基线和3个月时进行评估。主要结局是3个月时通过日常生活工具性活动(IADL)测量的身体功能变化。次要终点包括情绪变化(使用老年抑郁量表[GDS]评估)、生活质量(使用癌症治疗功能评估通用量表[FACT-G]评估)和预后理解。采用t检验和线性混合模型在每个时间点比较组间差异并评估纵向变化。

结果

共纳入80例患者(每组40例)。两组之间的临床特征平衡良好。大多数患者为女性(55.8%),平均年龄为74岁(范围65 - 88岁)。3个月时,GAIN-S组患者的身体功能(IADL,+1.8)、情绪(GDS,-2.7)、生活质量(FACT-G,+13.2)和症状负担(使用埃德蒙顿症状评估系统[ESAS]评估,-14.6)均有改善,所有P值均<.001。干预组患者对预后的理解也更准确(P<.01)。

结论

本研究证明了远程医疗管理的GAIN-S干预措施对巴西老年癌症患者的有效性。这些发现强调了为资源有限的环境量身定制GA指导干预措施的重要性。

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