Supporting Doctor-patient Communication in Oncology. A Randomized Controlled Trial (RCT) of Question Prompt List and Audio Recording as Communication Aids in Oncology Consultation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Difference in number of questions asked, and especially concerning prognosis.
研究概览
简要总结
Aims of study While various communication aids have been evaluated separately, no studies have taken a coordinated approach combining aids with different goals to evaluate their combined impact. In this study the investigators will use two communication aids; a QPL and an audio recording of the consultation. QPLs includes question concerning treatment options, but few studies involving QPLs have explored whether QPLs result in patients taking a more active role in the consultation. To our knowledge there have not been studies which objectively try to explore whether patients receiving QPLs participates in shared decision making to a greater extent, except for one ongoing Italian trial of breast cancer patients.
To explore and describe how communication aids as a QPL and an audio recording of the consultation improve the first doctor-patient consultation at the oncology outpatient clinic by
- Encouraging patients/caregivers to ask more questions, particularly about sensitive topics such as prognosis (as an effect of QPL alone)
- Increasing shared decision-making (as an effect of QPL alone)
- Improving overall satisfaction with the consultation and information retrieved (as an effect of both communication aids)
- Affecting quality of life/anxiety/depression (as an effect of both communication aids)
详细描述
Methods/study plan
- Translation of QPL to Norwegian
- Reference group
- Pilot project
- RCT
1. Translation of Question Prompt List (QPL) and evaluation of Norwegian version This QPL consists of a list of 49 questions covering 9 topics and is not yet used in Norway nor translated into Norwegian. Our collaborating partners , professor Phyllis Butow and professor Martin Tattersal at the Centre for Medical Psychology and Evidence-based Decision-making at the University of Sydney have developed several QPLs for different settings. In collaboration with prof. Butow and colleagues we have selected the QPL "Questions to ask your medical or radiation oncologist" which can be considered as suitable for the consultation at the outpatient oncology clinic at the University hospital of North Norway and will be translated to Norwegian.
The translation of the QPL will be done in 5 steps using the European organization for research and treatment of cancer (EORTC) gold-standard approach
- Two independent translators with Norwegian as their mother tongue translate QPL from English to Norwegian.
- Merge of the two translations after discussion between the two translators and the study coordinator.
- Back translation into English of an independent third translator.
- Discussion of the translation in a committee of researchers and clinicians. The versions agreed on will be the prefinal version.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Norwegian speaking cancer patients at their first consultation at the outpatient clinic with newly diagnosed cancer or relapse of cancer.
- •Age 18 and above who has given written informed consent to participate in the study.
排除标准
- •Mental impairment which will make informed consent difficult to retrieve.
- •Not having access to computer/device to listen to audio file.
研究组 & 干预措施
Control group
No intervention.
Communication aids
Patients in the intervention group will receive the QPL at home in advance of the consultation along with information about the clinic.The consultations will be recorded in both the control and intervention group. The recording will be done on the computer, and the patients in the intervention group will be given the recording immediately after the consultation on a memory stick.
干预措施: Communication aids (Other)
结局指标
主要结局
Difference in number of questions asked, and especially concerning prognosis.
时间窗: At day of first consultation
Analysis of the audio recorded consultations Collaborators of the investigators in Sydney have developed a manual and coding sheet to enable standardization of the coding procedure for the consultations with "Question prompt lists". This will be translated to Norwegian. The audio recordings will be transcribed and patients questions and concerns will be counted and categorized according to topics covered by the QPL. Physician endorsement of the QPL will be coded as either absent, basic or extended.
次要结局
- Difference in shared decision making(At day of first consultation)