跳至主要内容
临床试验/NCT01803061
NCT01803061已完成不适用

Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care

Danish Cancer Society2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Prevalence of late effects

研究概览

简要总结

Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making.

The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients.

Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time.

To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment

排除标准

  • •Patients with recurrence of their cancers and patients still in treatment.

研究组 & 干预措施

WebCan

Experimental

Provides computerized PRO to the treating physician at the point of care

干预措施: WebCan (Behavioral)

Usual care

No Intervention

结局指标

主要结局

Prevalence of late effects

时间窗: baseline, 6 and 12 months follow-up

次要结局

  • Quality of life(baseline, 6 and 12 months follow-up)

研究者

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

Trille Kjær

Phd student

Danish Cancer Society

研究点 (2)

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