一项改善肺癌患者家庭照顾者支持性护理的干预措施的有效性：一项随机对照试验的研究方案
Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial.
作者信息
Aubin Michèle, Vézina Lucie, Verreault René, Simard Sébastien, Desbiens Jean-François, Tremblay Lise, Dumont Serge, Fillion Lise, Dogba Maman Joyce, Gagnon Pierre
机构信息
Research Centre of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ), Quebec, QC, Canada.
Research Centre of Primary Care and Services-Université Laval (CERSSPL-UL), Quebec, QC, Canada.
出版信息
Trials. 2017 Jul 4;18(1):304. doi: 10.1186/s13063-017-2044-y.
BACKGROUND
Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on patients, with little attention to their FC. To fill this gap, a pragmatic intervention has been designed to improve supportive care for FC of patients with lung cancer. This article describes the study protocol of a single-center randomized controlled trial to assess its effectiveness.
METHODS/DESIGN: A total of 120 lung cancer patients and their FC are randomly assigned to the experimental group (exposed to intervention, N = 60) or to the control group (usual care, N = 60). The intervention includes: (1) systematic FC distress screening and problem assessment near their relative's cancer diagnosis, and every 2 months, (2) privileged contact with an oncology nurse (ON) away from the patient to address FC problems and (3) liaison by the ON with the family physician of FC reporting high distress (thermometer score ≥5/10), or problems relying on FP expertise. In both groups, FC, patient and process-of-care outcomes are measured at baseline and every 3 months, up to 9 months. The primary endpoint is FC distress measured by the Hospital Anxiety and Depression Scale (HADS) and the Psychological Distress Index used in the Quebec Health Survey (PDQHS). Individual interviews with 10 FC and a focus group with the oncology team will be conducted at the study end to further document the effectiveness of the intervention and its impact on quality of life (for FC) and practice organization (for the oncology team).
DISCUSSION
This trial will assess the effectiveness of an innovative intervention based on interprofessional collaboration between primary care and oncology care. It targets a population in great need, yet often neglected, and has the potential to clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02531464 . Registered on 15 July 2015.
背景
家庭护理人员（FC）通常比他们患癌症的亲属承受更高程度的痛苦。许多癌症中心已经实施了痛苦筛查项目，但其中大多数将精力集中在患者身上，很少关注其家庭护理人员。为了填补这一空白，设计了一项务实的干预措施，以改善对肺癌患者家庭护理人员的支持性护理。本文描述了一项单中心随机对照试验的研究方案，以评估其有效性。
方法/设计：总共120名肺癌患者及其家庭护理人员被随机分配到实验组（接受干预，N = 60）或对照组（常规护理，N = 60）。干预措施包括：（1）在其亲属癌症诊断时以及之后每2个月对家庭护理人员进行系统的痛苦筛查和问题评估；（2）家庭护理人员与肿瘤护士（ON）在远离患者的情况下进行特权接触，以解决家庭护理人员的问题；（3）肿瘤护士与家庭护理人员的家庭医生进行联络，报告高度痛苦（温度计评分≥5/10）或依赖家庭医生专业知识的问题。在两组中，对家庭护理人员、患者和护理过程结果在基线时以及每3个月进行测量，直至9个月。主要终点是通过医院焦虑和抑郁量表（HADS）以及魁北克健康调查中使用的心理痛苦指数（PDQHS）来衡量的家庭护理人员的痛苦程度。在研究结束时，将对10名家庭护理人员进行个体访谈，并与肿瘤团队进行焦点小组讨论，以进一步记录干预措施的有效性及其对生活质量（针对家庭护理人员）和实践组织（针对肿瘤团队）的影响。
讨论
该试验将评估基于初级护理和肿瘤护理之间跨专业合作的创新干预措施的有效性。它针对的是一个急需帮助但经常被忽视的人群，并且有可能显著改善患者和护理人员的癌症护理体验，并减轻疾病负担。
试验注册
ClinicalTrials.gov，ID：NCT02531464。于2015年7月15日注册。
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