此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer (EQUIP)

2018年3月28日 更新者:National Cancer Centre, Singapore

Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer

i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).

ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.

iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.

All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.

A total sample of 60 patients (30 in each arm) will be recruited.

Clinical Significance

If successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

69

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、169610
        • National Cancer Centre Singapore

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria

  • Has stage 3 or 4 lung cancer
  • ECOG 0,1 or 2
  • Able and willing to participate in the EQUIP programme

Exclusion criteria

- Unable to communicate in English or Mandarin

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

Participants in the EQUIP intervention group will individually receive four face-to-face sessions with a palliative care nurse.

For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.

Patients in the EQUIP intervention group will receive four face-to-face sessions. The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
无干预:Control
For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality of life
大体时间:4 weeks
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
4 weeks
Quality of life
大体时间:8 weeks
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
8 weeks
Quality of life
大体时间:12 weeks
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
12 weeks
Psychological distress
大体时间:4 weeks
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
4 weeks
Psychological distress
大体时间:8 weeks
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
8 weeks
Psychological distress
大体时间:12 weeks
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
12 weeks

次要结果测量

结果测量
大体时间
Number of participants with referral to palliative care services
大体时间:6 months
6 months
Number of hospital admissions
大体时间:6 months
6 months
Number of visits to the emergency department
大体时间:6 months
6 months

其他结果措施

结果测量
大体时间
总生存期
大体时间:1年
1年
Number of participants who died at home
大体时间:1 year
1 year
Number of participants with anti-cancer therapy in the last 4 weeks of life
大体时间:Last four weeks of life
Last four weeks of life

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (实际的)

2017年1月20日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2016年6月9日

首先提交符合 QC 标准的

2016年6月13日

首次发布 (估计)

2016年6月16日

研究记录更新

最后更新发布 (实际的)

2018年3月29日

上次提交的符合 QC 标准的更新

2018年3月28日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • NCCSPG-YR2016-JAN-15

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅