REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Odense University Hospital, Vestergade 17, Nyborg, DK-5800, Denmark.
Department of Nursing and Nutrition, University College Copenhagen, Sigurdsgade 26, DK-2200, Copenhagen N, Denmark.
Nutr J. 2020 Mar 17;19(1):21. doi: 10.1186/s12937-020-00539-7.
Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to use. The trial objectives are: 1) To test the effect of a multidisciplinary residential nutritional rehabilitation programme compared to standard care on the primary outcome body weight and secondary outcomes health-related quality of life, physical function and symptoms of anxiety and depression in patients curatively treated for HNC and 2) To test for correlations between participants' development in outcome scores during their participation in the programme and their baseline scores in Nutritional Risk Screening 2002 (NRS 2002), the Scored Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), and M. D. Anderson Dysphagia Inventory (MDADI) and to assess sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores.
In a randomised controlled trial, 72 patients treated for HNC recruited through a nationwide survey will be randomised to a multidisciplinary residential nutritional rehabilitation programme or to a wait-list control group. Data are collected at baseline, three and six months. Primary outcome is change in body weight, and secondary outcomes include changes in quality of life, physical function and symptoms of anxiety and depression. Potential correlations between intervention effect and baseline scores in NRS 2002, PG-SGA-SF and MDADI will be tested, and sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores will be assessed.
This is the first randomised controlled trial to test the effect of a multidisciplinary residential nutritional rehabilitation programme in patients treated for HNC. Recruitment through a nationwide survey gives a unique possibility to describe the trial population and to identify potential selection bias. As the trial will explore the potential of different nutrition screening and assessment tools in the assessment of rehabilitation needs in patients treated for HNC, the trial will create knowledge about how selection and prioritisation of nutritional rehabilitation aimed at patients treated for HNC should be offered. The results may contribute to a better organisation and use of existing resources in benefit of patients treated for HNC.
The trial is registered by The Danish Data Protection Agency (registration 2012-58-0018, approval number 18/14847) and the Regional Committees on Health Research Ethics for Southern Denmark (journal number 20182000-165). ClinicalTrials.gov Identifier: NCT03909256. Registered April 9, 2019.
在头颈部癌症（HNC）治疗患者中，饮食问题经常影响生活质量以及身体、心理和社会功能。住院康复计划可能会改善这些不良影响，但并非适用于所有患者。系统的康复需求评估可以优化资源的使用，同时确保有需要的患者得到康复治疗。然而，目前缺乏关于应使用哪种营养筛查和评估工具的证据。本试验的目的是：1）比较多学科住院营养康复计划与标准护理对 HNC 根治性治疗患者的体重主要结局和健康相关生活质量、身体功能以及焦虑和抑郁症状的次要结局的影响，2）检测在参与该计划过程中参与者的结局评分的变化与营养风险筛查 2002 （NRS 2002）、患者自评主观整体评估简短形式（PG-SGA SF）和 MD 安德森吞咽障碍量表（MDADI）的基线评分之间的相关性，并评估这三种工具在与临床相关的结局评分改善方面的灵敏度、特异性和预测值。
在一项随机对照试验中，通过全国性调查招募的 72 例 HNC 治疗患者将被随机分配至多学科住院营养康复计划组或等待名单对照组。数据在基线、3 个月和 6 个月时收集。主要结局为体重变化，次要结局包括生活质量、身体功能和焦虑抑郁症状的变化。将检测干预效果与 NRS 2002、PG-SGA-SF 和 MDADI 的基线评分之间的潜在相关性，并评估这三种工具在与临床相关的结局评分改善方面的灵敏度、特异性和预测值。
这是首个测试多学科住院营养康复计划在 HNC 治疗患者中的效果的随机对照试验。通过全国性调查招募可以为描述试验人群和确定潜在选择偏倚提供独特的可能性。由于该试验将探索不同营养筛查和评估工具在评估 HNC 治疗患者康复需求方面的潜力，因此该试验将为如何提供针对 HNC 治疗患者的营养康复选择和优先级提供知识。结果可能有助于更好地组织和利用现有资源，使 HNC 治疗患者受益。
该试验由丹麦数据保护局（注册号 2012-58-0018，批准号 18/14847）和南丹麦地区伦理委员会（期刊号 20182000-165）注册，并在 ClinicalTrials.gov 上注册（登记号 NCT03909256）。登记日期：2019 年 4 月 9 日。
