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临床试验/NCT02228200
NCT02228200已完成不适用

A Nurse-led Care Program on Quality of Life and Health Care Utilization for Cancer Patients in a Chemotherapy Day Center: A Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Change in quality of life

研究概览

简要总结

A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting was formulated. The aim of the study was to assess the effect of this nurse-led care program on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day center in terms of quality of life, symptom experiences, self-efficacy, health care utilization, and satisfaction with care. Specifically, the objectives are:

  • To compare the differences of health care utilization between the two arms.
  • To compare the differences of cancer patients' satisfaction with care between the two arms.
  • To explore the experiences of cancer patients in the intervention arm.
  • To understand the experiences of the intervention nurses of the program and their opinions on further development.

详细描述

Chemotherapy affects cancer patients in many ways. It is common that patients suffer multiple side-effects simultaneously. Psychological distress is also a common problem during chemotherapy. Distressful experiences in chemotherapy may lead to deterioration in a patient's of quality of life (QOL). In addition, cancer patients have particularly high unmet needs during treatment, including informational needs, psychosocial needs, needs in the activities of daily living, supportive care needs, sexual needs, and communication needs. Among them, information is the most frequently reported need in the treatment phase. These unmet needs cause uncertainty, anxiety, and distress to cancer patients.

Outpatient-based chemotherapy is now widely established. Despite its benefits to health care institutions and cancer patients, there are attendant challenges. Cancer patients need to take care of themselves at home during each interval of chemotherapy. Without adequate support from health care providers, cancer patients may not be able to properly manage chemotherapy and its effects by themselves. The poor management of side-effects may lead to increased health care utilization. Cancer patients need to develop new self-care skills to cope with chemotherapy.

Facing increasing numbers of cancer patients and burgeoning health care needs, health care professionals must address the issue of how to improve the quality of care during chemotherapy. Nurse-led care is a highly recommended and innovative way of improving quality of care. It shows distinct advantages in terms of providing holistic care because it is based on the philosophy of the uniqueness of individuals and the multidimensionality of human beings. The feasibility and effects of nurse-led care are being explored in an increasing number of studies. However, studies of nurse-led care for cancer patients receiving outpatient-based chemotherapy are far away adequacy. There is a need to examine the feasibility and effects of nurse-led care for cancer patients receiving chemotherapy in outpatient settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with primary breast /lung/stomach/colorectal cancer;
  • Receive chemotherapy for the first time;
  • Karnofsky performance scale equal or over 60;
  • Communicate with Cantonese and read Chinese;
  • Can be contacted with telephone.

排除标准

  • Having a history of psychiatric or intellectual impairment such as: dementia, schizophrenia, mental retardation, depression, and anxiety disorder;
  • Having received CT before either in the study hospital or other hospital;
  • Receive concurrent chemoradiotherapy;
  • At the end stage of life.

结局指标

主要结局

Change in quality of life

时间窗: T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).

Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)

次要结局

  • Health care utilization(During chemotherapy (i.e. from week 0 to week 20))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Shirley Siu Yin CHING

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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