Cluster randomised controlled trial dataset: Medical oncologist and cancer patient consultations and associated clinical data

This dataset relates to a cluster randomised controlled trial in which the intervention was an information and decision making resource: the Australian Cancer Trials (ACT) web site (www.australiancancertrials.gov.au). The cluster randomised controlled trial investigated the impact of the intervention on doctor-patient discussions about clinical trial awareness and participation. The ACT website is intended for patients, doctors and carers, and contains information about cancer trials, including clinical trials that are currently recruiting participants within Australia. The website also contains decision making support tools, in order to help patients decide, in consultation with their specialist, whether to join a clinical trial. Information on the ACT website is drawn from two cancer trial registries, the Australian New Zealand Clinical Trials Registry (ANZCTR) and ClinicalTrials.gov.
The primary goal of the trial was to identify whether doctors and patients who had access to the intervention (website) discussed clinical trials more than the control group, who did not have access. Secondary outcomes included clinical trial recruitment, patient knowledge about clinical trials, and whether the intervention had an effect on the patient’s ability to make a decision to join a clinical trial.
A cluster sample of thirty medical oncologists and 493 patients were recruited from 30 metropolitan and rural sites in New South Wales and Victoria, Australia. A baseline questionnaire was used to collect patient demographic and other clinical information (including cancer type and stage). This data was recorded in a Microsoft Access database. Consultations between medical oncologists and their patients were audio-recorded and transcribed into text files, and linked to demographic and clinical information. A follow-up questionnaire was administered, measuring patient knowledge of clinical trials and patient decision conflict about whether to join a clinical trial. Transcripts were de-identified, and coded in Nvivo according to a pre-defined coding schema.
The dataset comprises approximately 500 audio files (Windows Media Audio format), 500 associated de-identified interview transcripts (MS Word), an Access database of clinical data, coded interview data (MS Excel), and two master spreadsheets (MS Excel). Coded interview and questionnaire responses, transcript ID numbers, doctor ID numbers, patient ID numbers and associated clinical data were merged into two master spreadsheets by biostatistician Dr Kevin McGeechan. For further information regarding the project, methodology and findings please refer to the publications below.
Project contributors included Professor Alexandra Barratt; Professor David Currow; Professor Martin Tattersall; Professor Phyllis Butow; Associate Professor Lisa Askie; Dr Kevin McGeechan; Ms Sally Crossing (Chair of Cancer Voices NSW) and Dr Rachel Dear.

本数据集关联一项整群随机对照试验，试验干预措施为一款信息与决策辅助资源：澳大利亚癌症试验（Australian Cancer Trials, ACT）官方网站（www.australiancancertrials.gov.au）。此项整群随机对照试验探究了该干预措施对医患间关于临床试验认知与参与度沟通的影响。ACT网站面向患者、医师及护理者打造，涵盖澳大利亚境内当前正在招募受试者的癌症相关临床试验信息，同时配备决策支持工具，以协助患者与专科医生共同商议是否参与临床试验。该网站的信息源自两个癌症试验注册库：澳大利亚新西兰临床试验注册库（Australian New Zealand Clinical Trials Registry, ANZCTR）与ClinicalTrials.gov。

本试验的首要目标为明确使用该干预措施（即该网站）的医患群体，是否较未使用该措施的对照组更多地开展临床试验相关沟通。次要结局指标包括临床试验受试者招募情况、患者对临床试验的认知水平，以及该干预措施对患者做出参与临床试验决策的能力所产生的影响。

研究从澳大利亚新南威尔士州与维多利亚州的30个城市及乡村医疗站点招募了30名医学肿瘤医师与493名患者作为整群样本。研究采用基线问卷收集患者人口统计学信息及其他临床资料（包括癌症类型与分期），相关数据记录于Microsoft Access数据库中。对医学肿瘤医师与其患者的诊疗会诊过程进行录音并转录为文本文件，同时将转录文本与患者的人口统计学及临床信息进行关联。后续向患者发放随访问卷，以评估其对临床试验的认知水平及参与临床试验决策时的冲突程度。所有转录文本均已完成去标识化处理，并依据预先设定的编码框架在Nvivo软件中进行编码。

本数据集包含约500个音频文件（格式为Windows Media Audio）、500份对应的去标识化访谈转录文本（格式为MS Word）、一份临床资料Microsoft Access数据库、编码后的访谈数据（MS Excel格式），以及两份主电子表格（MS Excel格式）。生物统计学家Kevin McGeechan博士已将编码后的访谈与问卷应答数据、转录文本ID、医师ID、患者ID及关联临床资料合并至两份主电子表格中。如需了解该项目的更多信息、研究方法与研究结果，请参阅下文所列的出版物。

本项目的贡献者包括Alexandra Barratt教授、David Currow教授、Martin Tattersall教授、Phyllis Butow教授、Lisa Askie副教授、Kevin McGeechan博士、Sally Crossing女士（新南威尔士州癌症之声主席）以及Rachel Dear博士。