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方案论文:多中心、整群随机临床试验,旨在优化化疗后老年癌症幸存者的功能结局。

Protocol paper: Multi-site, cluster-randomized clinical trial for optimizing functional outcomes of older cancer survivors after chemotherapy.

机构信息

Division of Supportive Care in Cancer, Department of Surgery, University of Rochester Medical Center School of Medicine and Dentistry, Rochester, NY, USA; Geriatric Oncology Research, James P Wilmot Cancer Institute, University of Rochester Medical Center School of Medicine and Dentistry, Rochester, NY, USA.

Division of Supportive Care in Cancer, Department of Surgery, University of Rochester Medical Center School of Medicine and Dentistry, Rochester, NY, USA.

出版信息

J Geriatr Oncol. 2022 Jul;13(6):892-903. doi: 10.1016/j.jgo.2022.03.001. Epub 2022 Mar 12.


DOI:10.1016/j.jgo.2022.03.001
PMID:35292232
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9283231/
Abstract

BACKGROUND: Cancer survivors over the age of 65 have unique needs due to the higher prevalence of functional and cognitive impairment, comorbidities, geriatric syndromes, and greater need for social support after chemotherapy. In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes important to older cancer survivors following chemotherapy. METHODS: A cluster-randomized trial will be conducted in approximately 30 community oncology practices affiliated with the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participating sites will be randomized to the GEMS intervention, which includes Advanced Practice Practitioner (APP)-directed geriatric evaluation and management (GEM), and Survivorship Health Education (SHE) that is combined with Exercise for Cancer Patients (EXCAP©®), or usual care. Cancer survivors will be recruited from community oncology practices (of participating oncology physicians and APPs) after the enrolled clinicians have consented and completed a baseline survey. We will enroll 780 cancer survivors aged 65 years and older who have completed curative-intent chemotherapy for a solid tumor malignancy within four weeks of study enrollment. Cancer survivors will be asked to choose one caregiver to also participate for a total up to 780 caregivers. The primary aim is to compare the effectiveness of GEMS for improving patient-reported physical function at six months. The secondary aim is to compare effectiveness of GEMS for improving patient-reported cognitive function at six months. Tertiary aims include comparing the effectiveness of GEMS for improving: 1) Patient-reported physical function at twelve months; 2) objectively assessed physical function at six and twelve months; and 3) patient-reported cognitive function at twelve months and objectively assessed cognitive function at six and twelve months. Exploratory health care aims include: 1) Survivor satisfaction with care, 2) APP communication with primary care physicians (PCPs), 3) completion of referral appointments, and 4) hospitalizations at six and twelve months. Exploratory caregiver aims include: 1) Caregiver distress; 2) caregiver quality of life; 3) caregiver burden; and 4) satisfaction with patient care at six and twelve months. DISCUSSION: If successful, GEMS would be an option for a standardized APP-led survivorship care intervention. TRIAL REGISTRATION: ClinicalTrials.govNCT05006482, registered on August 9, 2021.

摘要

背景:由于功能和认知障碍、合并症、老年综合征的患病率较高,以及化疗后对社会支持的需求更大,65 岁以上的癌症幸存者有独特的需求。在这项研究中,我们将评估老年综合评估和管理-生存(GEMS)干预是否能改善化疗后老年癌症幸存者重要的功能结局。

方法:一项集群随机试验将在罗切斯特大学癌症中心(URCC)国家癌症研究所社区肿瘤学研究计划(NCORP)研究基地附属的大约 30 个社区肿瘤学实践中进行。参与的站点将被随机分配到 GEMS 干预组,包括高级执业医师(APP)指导的老年综合评估和管理(GEM),以及与癌症患者运动(EXCAP©®)相结合的生存健康教育(SHE),或常规护理。癌症幸存者将在参与的肿瘤医生和 APP 同意并完成基线调查后,从社区肿瘤学实践中招募。我们将招募 780 名年龄在 65 岁及以上、在研究入组后四周内完成根治性化疗的实体瘤恶性肿瘤的癌症幸存者。要求癌症幸存者选择一名照顾者共同参与,最多可选择 780 名照顾者。主要目的是比较 GEMS 在改善 6 个月时患者报告的身体功能方面的有效性。次要目的是比较 GEMS 在改善 6 个月时患者报告的认知功能方面的有效性。三级目标包括比较 GEMS 在以下方面的有效性:1)12 个月时患者报告的身体功能;2)6 个月和 12 个月时的客观评估身体功能;以及 3)6 个月和 12 个月时患者报告的认知功能和客观评估的认知功能。探索性的医疗保健目标包括:1)幸存者对护理的满意度;2)APP 与初级保健医生(PCP)的沟通;3)转诊预约的完成情况;以及 4)6 个月和 12 个月时的住院情况。探索性的照顾者目标包括:1)照顾者的痛苦;2)照顾者的生活质量;3)照顾者的负担;以及 4)6 个月和 12 个月时患者护理的满意度。

讨论:如果成功,GEMS 将是一种标准化 APP 主导的生存护理干预措施的选择。

试验注册:ClinicalTrials.govNCT05006482,于 2021 年 8 月 9 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf7a/9283231/7ca0c9fe4982/nihms-1790471-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf7a/9283231/53432c59e677/nihms-1790471-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf7a/9283231/7ca0c9fe4982/nihms-1790471-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf7a/9283231/53432c59e677/nihms-1790471-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf7a/9283231/7ca0c9fe4982/nihms-1790471-f0002.jpg

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[1]
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