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临床试验/NCT00964522
NCT00964522已完成不适用

Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy

Instituto de Salud Carlos III2 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
266
试验地点
2
主要终点
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).

研究概览

简要总结

The purpose of this study is to evaluate the effects of a nurse education and care program for patients with breast cancer, in terms of use of the health services, quality of life, satisfaction and security.

Hypothesis:

Nurse education and care program will reduce the use of health resources and will improve the toxicity, quality of life and satisfaction of the patients with breast cancer who initiate chemotherapy.

详细描述

Design: randomized controlled clinical trial with non-pharmacologic intervention. Subjects and setting of study: patients with breast cancer who initiate adjuvant, neoadjuvant or palliative chemotherapy, in the Day Unit of a University Hospital. Interventions: random allocation of the patients in two arms according to the nursing cares. The arm A is the one of standard education and care. They consist of receiving programmed oral and written information by the specialist in Medical Oncology before initiating the chemotherapy treatment and before each cycle of treatment. Also, the patients will be able to ask for information to the nurses when they need it. Arm B is the one of experimental education and care. They consist of receiving oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle. In addition, the patients assigned to arm B will receive programmed education and care about the chemotherapy by a nurse of the Medical Oncology service before the beginning of the treatment and in each cycle, in a specific nurse consultation. Determinations: use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). Toxicity caused by the chemotherapy. Patients who leave the chemotherapy by serious toxicity. Quality of life measured by means of the EORTC QOL-C30 questionnaire. Satisfaction with the received medical assistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
Female
接受健康志愿者

入选标准

  • Patients with breast cancer who initiate adjuvant, neoadjuvant or palliative chemotherapy.
  • Performance status 0-2 (ECOG).
  • Outpatients.
  • Normal hematopoietic, hepatic, renal, cardiac and lung functions.
  • Must be able to sign the informed consent

排除标准

  • Contraindication for chemotherapy
  • Inpatients
  • Simultaneously radiotherapy and endocrine therapy.

结局指标

主要结局

Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).

时间窗: one year

次要结局

  • Toxicity.(one year)
  • Quality of life.(one year)
  • Satisfaction(one year)

研究者

发起方
Instituto de Salud Carlos III
申办方类型
Other Gov

研究点 (2)

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