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临床试验/NCT01091584
NCT01091584已完成不适用

A Randomized Trial to Assess the (Cost) Effectiveness of the Use of the Distress Thermometer by a Nurse in Addition to Usual Care for Patients Treated With Curative Intent for Breast Cancer.

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2010年3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
193
试验地点
2
主要终点
Subscale quality of life of the questionnaire: EORTC QLQ C30

研究概览

简要总结

The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Histologically proven malignancy of the breast
  • Curative treatment
  • Dominated the dutch language
  • Age > 18 year

排除标准

  • Previously treated for a malignancy
  • Psychiatric problems that adherence this study

结局指标

主要结局

Subscale quality of life of the questionnaire: EORTC QLQ C30

时间窗: After each treatment completion, during follow up; first year every 3 months, second year every 6 months

Subscale quality of life of the questionnaire: EORTC QLQ C30

次要结局

  • Other subscales(After each treatment completion, during follow up; first year every 3 months, second year every 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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