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Abstract：
BACKGROUND: Informal caregivers (ICs) of patients with cancer provide essential and mainly uncompensated care. A self-perceived preparedness to care for the patient is associated with a lower caregiver burden, described as the extent to which caregiving is perceived as having adverse effects on IC functioning and well-being. ICs\' well-being is associated with patient-perceived quality of care, suggesting that interventions to optimize ICs\' health are essential in order to improve patient care. Head and neck cancer (HNC) is the seventh most common malignant disease in the world. The disease and its treatment have a significant negative impact on the patient\'s health and quality of life. Symptoms usually interfere with swallowing, food and fluid intake, breathing, speaking, and communication. ICs frequently manage patients\' symptoms and side effects, especially problems related to nutrition and oral pain, without being properly prepared. Carer eSupport is an Internet-administered intervention, based on focus group discussions with ICs, developed in collaboration with ICs and healthcare professionals, tested for feasibility, and deemed feasible. This study protocol outlines the methods of investigating the effects of Carer eSupport plus support as usual (SAU) on self-reported preparedness for caregiving, caregiver burden, and well-being in the ICs of patients with HNC, compared with ICs receiving SAU only.
METHODS: In this randomized controlled trial, 110 ICs of patients with HNC, undergoing radiotherapy combined with surgery and/or medical oncological treatment, will be randomized (1:1) to Carer eSupport plus SAU or SAU only. Data will be collected at baseline (before randomization), post-intervention (after 18 weeks), and 3 months after post-intervention. The primary outcome is self-reported preparedness for caregiving. Secondary outcomes are self-reported caregiver burden, anxiety, depression, and health-related quality of life. The effect of Carer eSupport plus SAU on preparedness for caregiving and secondary outcomes, compared with SAU only, will be evaluated by intention to treat analyses using linear regression models, mixed-model regression, or analysis of covariance.
CONCLUSIONS: If proven effective, Carer eSupport has the potential to significantly improve ICs\' preparedness for caregiving and their wellbeing, thereby improving patient-perceived quality of care and patient wellbeing.
BACKGROUND: ClinicalTrials.gov; NCT06307418, registered 12.03.2024 (https://clinicaltrials.gov/search? term=NCT06307418).
METHODS: In this randomized controlled trial, 110 ICs of patients with HNC, undergoing radiotherapy combined with surgery and/or medical oncological treatment, will be randomized (1:1) to Carer eSupport plus SAU or SAU only. Data will be collected at baseline (before randomization), post-intervention (after 18 weeks), and 3 months after post-intervention. The primary outcome is self-reported preparedness for caregiving. Secondary outcomes are self-reported caregiver burden, anxiety, depression, and health-related quality of life. The effect of Carer eSupport plus SAU on preparedness for caregiving and secondary outcomes, compared with SAU only, will be evaluated by intention to treat analyses using linear regression models, mixed-model regression, or analysis of covariance.
CONCLUSIONS: If proven effective, Carer eSupport has the potential to significantly improve ICs\' preparedness for caregiving and their wellbeing, thereby improving patient-perceived quality of care and patient wellbeing.
BACKGROUND: ClinicalTrials.gov; NCT06307418, registered 12.03.2024 (https://clinicaltrials.gov/search? term=NCT06307418).
摘要：
背景：癌症患者的非正式护理人员（IC）提供基本且主要是无偿的护理。自我感知的对患者的护理准备与较低的护理者负担相关，描述为护理被认为对IC功能和福祉产生不利影响的程度。IC\'幸福感与患者感知的护理质量有关，这表明优化IC健康的干预措施对于改善患者护理至关重要。头颈部肿瘤（HNC）是世界上第七大恶性肿瘤。该疾病及其治疗对患者的健康和生活质量有显著的负面影响。症状通常会干扰吞咽，食物和液体摄入量，呼吸,说话,和沟通。IC经常管理患者的症状和副作用，尤其是与营养和口腔疼痛有关的问题，没有做好准备。护理人员eSupport是一种互联网管理的干预措施，根据与IC的焦点小组讨论，与IC和医疗保健专业人员合作开发，可行性测试，并且被认为是可行的。本研究方案概述了调查护理者电子支持加支持照常（SAU）对自我报告的护理准备的影响的方法，照顾者的负担，以及HNC患者IC的幸福感，与仅接收SAU的IC相比。
方法：在这项随机对照试验中，HNC患者的110IC，接受放射治疗结合手术和/或内科肿瘤治疗，将随机(1：1)分配给CarereSupport加SAU或仅SAU。数据将在基线（随机化前）收集，干预后（18周后），干预后3个月。主要结果是自我报告的护理准备。次要结果是自我报告的照顾者负担，焦虑,抑郁症,和健康相关的生活质量。护工电子支持加SAU对护理准备和次要结果的影响，与仅SAU相比，将通过使用线性回归模型的意向处理分析进行评估，混合模型回归，或协方差分析。
结论：如果证明有效，护理人员eSupport有可能显著改善IC对护理和他们的健康的准备，从而提高患者感知的护理质量和患者福祉。
背景：ClinicalTrials.gov;NCT06307418，注册12.03.2024（https://clinicaltrials.gov/search?term=NCT06307418）。
方法：在这项随机对照试验中，HNC患者的110IC，接受放射治疗结合手术和/或内科肿瘤治疗，将随机(1：1)分配给CarereSupport加SAU或仅SAU。数据将在基线（随机化前）收集，干预后（18周后），干预后3个月。主要结果是自我报告的护理准备。次要结果是自我报告的照顾者负担，焦虑,抑郁症,和健康相关的生活质量。护工电子支持加SAU对护理准备和次要结果的影响，与仅SAU相比，将通过使用线性回归模型的意向处理分析进行评估，混合模型回归，或协方差分析。
结论：如果证明有效，护理人员eSupport有可能显著改善IC对护理和他们的健康的准备，从而提高患者感知的护理质量和患者福祉。
背景：ClinicalTrials.gov;NCT06307418，注册12.03.2024（https://clinicaltrials.gov/search?term=NCT06307418）。
