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OPTion随机对照试验的研究方案:关于在姑息治疗环境中对老年癌症患者的治疗目标进行优先排序的效果

Study protocol for the OPTion randomised controlled trial on the effect of prioritising treatment goals among older patients with cancer in a palliative setting.

作者信息

Stegmann M E, Schuling J, Hiltermann T J N, Reyners A K L, Burger H, Berger M Y, Berendsen A J

机构信息

University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.

University Medical Center Groningen, Department of General Practice, Groningen, The Netherlands.

出版信息

Maturitas. 2017 Feb;96:84-88. doi: 10.1016/j.maturitas.2016.11.014. Epub 2016 Nov 27.

DOI:10.1016/j.maturitas.2016.11.014
PMID:28041600
Abstract

PURPOSE

Traditionally, general practitioners (GPs) are not involved in cancer-related treatment decisions, despite their often long relationship with patients, and their unique position to explore patients' values, especially with older patients. Therefore, we designed a randomised controlled trial to study the effect, on self-efficacy related to treatment decisions, of a conversation about treatment goals between GPs and patients with cancer in a palliative setting.

METHODS

We aim to include 168 patients aged ≥70 years with a diagnosis of non-curable cancer, due to consult their oncologist about treatment options. In the intervention group, patients will consult their GP using an Outcome Prioritisation Tool (OPT). The control group will receive care as usual. The primary outcome will be the score on a decision self-efficacy scale after the consultation with the oncologist. Secondary outcomes will be symptoms of depression, anxiety, or fatigue. In an embedded observational study of the intervention group, we aim to assess the prioritisation of treatment goals (i.e., OPT scores), and their determinants, over a six-month period.

CONCLUSIONS

The OPTion study should provide relevant information about the effect on self-efficacy of a consultation between GPs and older patients with cancer, concerning preferred treatment goals in a palliative setting. Dutch Trial Register NTR5419.

摘要

目的

传统上,全科医生(GPs)并不参与癌症相关的治疗决策,尽管他们与患者的关系往往很长,且处于探索患者价值观的独特位置,尤其是对于老年患者。因此,我们设计了一项随机对照试验,以研究在姑息治疗环境中,全科医生与癌症患者之间关于治疗目标的对话对治疗决策自我效能的影响。

方法

我们旨在纳入168名年龄≥70岁、被诊断为不可治愈癌症且因治疗方案咨询肿瘤学家的患者。在干预组中,患者将使用结果优先排序工具(OPT)咨询他们的全科医生。对照组将接受常规护理。主要结局将是与肿瘤学家咨询后决策自我效能量表上的得分。次要结局将是抑郁、焦虑或疲劳症状。在对干预组的一项嵌入式观察研究中,我们旨在评估六个月内治疗目标的优先排序(即OPT得分)及其决定因素。

结论

OPTion研究应提供有关全科医生与老年癌症患者之间关于姑息治疗环境中首选治疗目标的咨询对自我效能影响的相关信息。荷兰试验注册编号NTR5419。

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引用本文的文献

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Support Care Cancer. 2021 Jul;29(7):3849-3856. doi: 10.1007/s00520-020-05945-5. Epub 2020 Dec 22.
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Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.老年不可治愈癌症患者治疗目标的优先排序:荷兰初级保健中 OPTion 随机对照试验。
Br J Gen Pract. 2020 Jun 25;70(696):e450-e456. doi: 10.3399/bjgp20X710405. Print 2020 Jul.