Fujisawa Daisuke, Umemura Shigeki, Okizaki Ayumi, Satomi Eriko, Yamaguchi Takuhiro, Miyaji Tempei, Mashiko Tomoe, Kobayashi Naoko, Kinoshita Hiroya, Mori Masanori, Morita Tatsuya, Uchitomi Yosuke, Goto Koichi, Ohe Yuichiro, Matsumoto Yoshihisa
Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.
Psycho-Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
BMJ Open. 2020 Nov 26;10(11):e037759. doi: 10.1136/bmjopen-2020-037759.
It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.
A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants' quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.
This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.
UMIN000025491.
有人认为，从疾病早期阶段就将姑息治疗纳入标准癌症治疗中，可以提高癌症患者的生活质量。在本文中，我们介绍了一项多中心随机对照试验的方案，以检验一项由护士主导、筛查触发的早期专科姑息治疗干预计划对晚期肺癌患者的有效性。
总共206名患者将被随机（1:1）分配到干预组或对照组（常规护理）。该干预由一个简短的自我管理筛查工具触发，包括由高级护士进行的全面需求评估、咨询和服务协调。主要结局是12周时癌症治疗功能评估（FACT）的试验结局指数。次要结局包括参与者的生活质量（FACT-肺癌）、抑郁（患者健康问卷-9）、焦虑（广泛性焦虑障碍-7）、疾病认知（预后与治疗认知问卷）、医疗服务使用情况和生存率。预计采用混合方法将深入了解这种干预的作用机制。
本研究已获得日本国立癌症中心机构审查委员会的批准（批准号：2016-235）。研究结果将通过同行评审出版物和会议报告进行传播，并将反馈到国家医疗政策中。
UMIN000025491。
