The effects of a family-centered psychosocial-based nutrition intervention in patients with advanced cancer: the PiCNIC2 pilot randomised controlled trial.

The effects of a family-centered psychosocial-based nutrition intervention in patients with advanced cancer: the PiCNIC2 pilot randomised controlled trial.
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以家庭为中心的基于心理社会的营养干预对晚期癌症患者的影响:PiCNIC2试点随机对照试验

DOI:
10.1186/s12937-020-00657-2
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发表时间:
2021-01-02
期刊:
影响因子:
5.4
通讯作者:
Lo RS
Lo RS
中科院分区:
医学2区
文献类型:
--
作者:
Molassiotis A;Brown T;Cheng HL;Byrnes A;Chan RJ;Wyld D;Eastgate M;Yates P;Marshall AP;Fichera R;Isenring L;To KF;Ko PS;Lam W;Lam YF;Au LF;Lo RS

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晚期癌症患者的营养不良很常见,但有限,关于营养干预措施的有效性存在不确定的数据。最近建立了一种新的以家庭为基础的营养心理社会干预的可行性和可接受性。本研究的目的是评估进行随机对照试验的可行性,后者的干预,试点测试结果的措施,并探讨初步结果。在澳大利亚和香港招募晚期癌症患者和家庭照顾者的初步随机对照试验。参与者被随机分配到两组中的一组,一组是以家庭为中心的营养干预组,另一组是仅接受常规护理的对照组。干预措施提供了2 - 3小时的直接营养师接触时间与患者和家庭成员超过4 - 6周的时间。在干预期间,通过营养咨询解决了营养影响症状和食物或饮食相关的心理社会问题,重点是改善两人之间与营养有关的沟通和制定营养目标。可行性评估包括招募、同意率、留存率和评估工具的可接受性。使用经验证的营养和生活质量自我报告措施收集患者和护理人员的结局数据,包括3天食物日记、患者生成的主观全面评估简表、功能评估厌食症/恶病质量表、进食相关的痛苦或享受以及自我效能、护理人员痛苦、焦虑和抑郁的措施。74名患者和54名家庭照顾者参加了这项研究。招募是具有挑战性的,对于每一个同意参与的患者,必须筛选14 - 31名患者。患者和照顾者的同意率分别为44%和55%。只有一半的参与者完成了试验的最终评估。数据显示,干预组的一些患者结局有希望,特别是与饮食相关的痛苦(澳大利亚数据p = 0.046;香港数据p = 0.07),与饮食相关的享受(香港数据p = 0.024)和生活质量(澳大利亚数据p = 0.045)的改善。能量和蛋白质摄入量也以临床上有意义的方式增加。然而,照顾者关于与饮食有关的痛苦、焦虑、抑郁和生育负担的数据几乎没有变化。尽管参与者招募面临挑战,但干预措施显示出对患者营养状况和饮食相关痛苦产生积极影响的良好潜力。这项试验的结果证明了一个更大的和充分的试验,以确定这种干预的有效性。该试验在澳大利亚和新西兰临床试验注册处注册,注册号ACTRN12618001352291。
Malnutrition in advanced cancer patients is common but limited and inconclusive data exists on the effectiveness of nutrition interventions. Feasibility and acceptability of a novel family-based nutritional psychosocial intervention were established recently. The aims of this present study were to assess the feasibility of undertaking a randomised controlled trial of the latter intervention, to pilot test outcome measures and to explore preliminary outcomes. Pilot randomised controlled trial recruiting advanced cancer patients and family caregivers in Australia and Hong Kong. Participants were randomised and assigned to one of two groups, either a family-centered nutritional intervention or the control group receiving usual care only. The intervention provided 2–3 h of direct dietitian contact time with patients and family members over a 4–6-week period. During the intervention, issues with nutrition impact symptoms and food or eating-related psychosocial concerns were addressed through nutrition counselling, with a focus on improving nutrition-related communication between the dyads and setting nutritional goals. Feasibility assessment included recruitment, consent rate, retention rate, and acceptability of assessment tools. Validated nutritional and quality of life self-reported measures were used to collect patient and caregiver outcome data, including the 3-day food diary, the Patient-Generated Subjective Global Assessment Short Form, the Functional Assessment Anorexia/Cachexia scale, Eating-related Distress or Enjoyment, and measures of self-efficacy, carers’ distress, anxiety and depression. Seventy-four patients and 54 family caregivers participated in the study. Recruitment was challenging, and for every patient agreeing to participate, 14–31 patients had to be screened. The consent rate was 44% in patients and 55% in caregivers. Only half the participants completed the trial’s final assessment. The data showed promise for some patient outcomes in the intervention group, particularly with improvements in eating-related distress (p = 0.046 in the Australian data; p = 0.07 in the Hong Kong data), eating-related enjoyment (p = 0.024, Hong Kong data) and quality of life (p = 0.045, Australian data). Energy and protein intake also increased in a clinically meaningful way. Caregiver data on eating-related distress, anxiety, depression and caregiving burden, however, showed little or no change. Despite challenges with participant recruitment, the intervention demonstrates good potential to have positive effects on patients’ nutritional status and eating-related distress. The results of this trial warrant a larger and fully-powered trial to ascertain the effectiveness of this intervention. The trial was registered with the Australian & New Zealand Clinical Trials Registry, registration number ACTRN12618001352291.
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