针对接受乳腺癌根治性治疗的患者，采用护士主导的、结合苦恼温度计的干预措施的有效性：一项随机对照试验的设计
The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial.
作者信息
Ploos van Amstel Floortje K, Prins Judith B, van der Graaf Winette T A, Peters Marlies E W J, Ottevanger Petronella B
机构信息
Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, 6500, Nijmegen, The Netherlands.
Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.
出版信息
BMC Cancer. 2016 Jul 25;16:520. doi: 10.1186/s12885-016-2565-x.
BACKGROUND
Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT on the psychosocial wellbeing of the patient are unknown. A study to assess the psychosocial consequences of the systematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer is needed.
METHODS/DESIGN: The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded randomized controlled trial. Patients treated with curative intent for breast cancer will be recruited from the Radboud University Medical Center. The intervention consists of the DT together with discussion of the results with the patient by a trained oncology nurse added to the usual care. Patients will be randomly allocated (1:1) to either receive usual care or the usual care plus the intervention. Primary outcome measure is global quality of life measured with the EORTC QLQ-C30. The functional and symptom scales of the EORTC QLQ-C30 and BR23, Hospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline and final measurement only) will be used to measure secondary outcomes. Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three and six months' interval during the first and second year respectively.
DISCUSSION
This study will be the first randomized controlled longitudinal study about the effectiveness of the DT as nurse led-intervention. In case of proven effectiveness, future implementation and standardization of use of the DT as part of routine care will be recommended.
TRIAL REGISTRATION
This study is registered at clinicaltrial.gov march 17, 2010 ( NCT01091584 ).
背景
癌症患者的痛苦会影响其生活质量。在全球范围内，推荐使用痛苦温度计（DT）对癌症患者进行痛苦筛查。然而，使用DT对患者心理社会幸福感的影响尚不清楚。需要开展一项研究，以评估系统使用DT及其由护士进行讨论与为原发性乳腺癌门诊患者提供的常规护理相比，对患者心理社会方面的影响。
方法/设计：在一项非盲随机对照试验中测试由护士主导的DT干预措施的有效性。将从拉德堡德大学医学中心招募接受乳腺癌根治性治疗的患者。干预措施包括DT以及由经过培训的肿瘤护士与患者讨论结果，并将其添加到常规护理中。患者将被随机分配（1:1）接受常规护理或常规护理加干预措施。主要结局指标是使用欧洲癌症研究与治疗组织核心问卷（EORTC QLQ-C30）测量的总体生活质量。EORTC QLQ-C30和BR23的功能及症状量表、医院焦虑抑郁量表、事件影响量表、疾病认知问卷以及DT（仅在基线和最终测量时使用）将用于测量次要结局。在基线、每种癌症治疗方式完成后以及随访期间，两组均需填写问卷，在第一年和第二年分别间隔三个月和六个月。
讨论
本研究将是第一项关于DT作为护士主导干预措施有效性的随机对照纵向研究。如果证明有效，将建议未来将DT作为常规护理的一部分进行实施和标准化使用。
试验注册
本研究于2010年3月17日在clinicaltrial.gov注册（NCT01091584）。
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