Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.
Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Tübingen, Germany.
Trials. 2020 May 27;21(1):434. doi: 10.1186/s13063-020-04321-2.
Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support. However, due to neurological and neurocognitive deficits, adequate assessment of distress and support needs remains challenging in clinical practice. The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap.
METHODS/DESIGN: This is a multicenter cluster randomized study with two arms. Randomization is done on a cluster level with 13 hospitals providing regular neuro-oncological outpatient services conducted by neurologists and/or neurosurgeons. The intervention will include an assessment of psychosocial distress of patients in doctor-patient conversation compared to assessment of psychosocial distress via questionnaire (control, standard of care). In total, 616 HGG patients will be enrolled. The outcome will be the number of HGG patients with increased psychosocial distress who receive professional support from psychosocial services. Secondary endpoints are inter alia number of patients reporting psychosocial distress and unmet needs detected correctly by the respective method; quality of life; psychological well-being and burden of the patients before and after doctor-patient consultation; as well as the length of the doctor-patient consultation.
Patients with HGG are confronted with an oncological diagnosis and at the same time with high symptom burden. This often leads to distress, which is not always adequately recognized and treated. So far, only a limited number of adequate instruments are available to assess HGG patient's distress. Yet, an adequate care and support network might facilitate the course of the disease and tumor therapies for patients. Our hypothesis is that an assessment conducted directly by attending doctors and in which the doctors talk to patients with HGG will be more effective than an assessment via a questionnaire, leading to better identifying patients in need of support. This may lead to an improvement of health care in these patients. Further, this method might be implemented also in other brain tumor patients (e.g., patients with brain metastases).
German Clinical Trials Register, DRKS00018079. Registered on 3rd September 2019.
高级别胶质瘤（HGG）患者通常会经历高度的痛苦，需要心理社会支持。然而，由于神经和神经认知方面的缺陷，在临床实践中，对痛苦和支持需求的充分评估仍然具有挑战性。本研究的目的是探讨在常规门诊咨询中系统地引入提示问题是否有助于缩小这一差距。
方法/设计：这是一项多中心集群随机研究，分为两组。随机分组在 13 家提供由神经科医生和/或神经外科医生进行的常规神经肿瘤学门诊服务的医院层面进行。干预措施将包括在医患对话中评估患者的心理社会痛苦，与通过问卷评估心理社会痛苦（对照组，标准护理）进行比较。总共将纳入 616 名 HGG 患者。主要结局是接受心理社会服务的 HGG 患者中，因心理社会困扰而增加的人数。次要结局包括通过各自方法正确检测到的报告心理社会困扰和未满足需求的患者人数；生活质量；患者在医患咨询前后的心理幸福感和负担；以及医患咨询的时间长度。
HGG 患者面临着癌症诊断，同时还面临着高症状负担。这常常导致痛苦，而痛苦往往没有得到充分的认识和治疗。到目前为止，只有少数足够的工具可以评估 HGG 患者的痛苦。然而，适当的护理和支持网络可能会为患者的疾病和肿瘤治疗带来便利。我们的假设是，由主治医生直接进行的评估，以及在评估中医生与 HGG 患者交谈，将比通过问卷评估更有效，从而更有效地确定需要支持的患者。这可能会改善这些患者的医疗保健。此外，这种方法也可以在其他脑肿瘤患者（例如，脑转移瘤患者）中实施。
德国临床试验注册处，DRKS00018079。注册于 2019 年 9 月 3 日。
