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临床试验/NCT01213745
NCT01213745Unknown不适用

A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 138 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
入组人数
138
试验地点
1
主要终点
To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life

研究概览

简要总结

This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.

详细描述

Patients with lung cancer who have completed a course of treatment (or who are in-between treatment) at the Royal Marsden Hospital would be eligible for inclusion in the study. Participants will be randomised into 3 groups. Group 1 - this group will complete the QoL questionnaire and will receive targeted therapies by a doctor (and other members of the oncology team) during a clinic consultation. Group 2 - will complete the QoL questionnaire however the questionnaire will not be seen by the doctor during a clinic consultation. Group 3 - the control group will not complete the QoL questionnaire before a clinic consultation. All patients will complete a diary of all contact they have with health care professionals during the study. The study will last for 6 weeks and at the end of the study all patients will complete the QoL questionnaire.

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
Single (Investigator)

入排标准

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

入选标准

  • •male or female age > 18 years
  • •patients who are able to adequately understand written and spoken english
  • •diagnosis of lung cancer (non small cell, small cell, mesothelioma)
  • •no plan to commence treatment (chemotheraphy, targeted therapies, radioterhapy, surgery) with 6 weeks
  • •both radically or palliatively treated patients remain eligible
  • •patients whose toxicities from their primary treatment has resolved or have stabilised for a period of 7 days

排除标准

  • •patients are taking part on any other QoL studies
  • •taking part in any other studies that requires QoL questionnaires, extra visits or investigations
  • •currently on treatment (chemotherapy, radiotherapy, surgery or targeted therapies)
  • •they have on going toxicities from their treatment which have not been stablised (required intervention within last 7 days)

研究组 & 干预措施

Intervention

Experimental

干预措施: Intervention (Other)

Attention

Experimental

干预措施: Attention (Other)

Control

Active Comparator

干预措施: Control (Other)

结局指标

主要结局

To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life

次要结局

  • To investigate whether the use of EORTC QLQ-C30 + lung cancer module results in less patient contact with health care professionals during the 6 week study period for the 3 groups

研究者

申办方类型
Other

研究点 (1)

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