Wakefield Claire E, Doolan Emma L, Fardell Joanna E, Signorelli Christina, Quinn Veronica F, Tucker Kathy F, Patenaude Andrea F, Marshall Glenn M, Lock Richard B, Georgiou Gabrielle, Cohn Richard J
Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.
School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2018 Aug 8;8(8):e024064. doi: 10.1136/bmjopen-2018-024064.
Patient-derived xenografts (PDXs) have the potential to transform personalised cancer care, however, little is known about the acceptability of using PDXs to guide treatment decision-making. Given that patient and community preferences can influence satisfaction with care as well as the success of new technologies, we will evaluate the acceptability of PDXs in individuals affected by cancer and community comparisons.
This comparative cross-sectional study will recruit 323 individuals affected by cancer (cancer survivors (of childhood or adult cancer) and parents of childhood cancer survivors) and 323 community comparisons (adults and parents). We will collect data via structured interviews and questionnaires. To determine the acceptability of PDXs, we will assess five domains: willingness to use PDXs when/if diagnosed with cancer, perceived advantages and disadvantages of PDXs, maximum acceptable out-of-pocket costs per patient, maximum acceptable turnaround time to receive results and maximum acceptable number of mice sacrificed per patient. The primary endpoint will be participants' decisional balance ratio (calculated as participants' advantages ratings divided by perceived disadvantages ratings).
The study protocol has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee (HREC:12/173) and UNSW Sydney (HC15773). The results will be disseminated in peer-reviewed journals and at scientific conferences. A lay summary will be published on the Behavioural Sciences Unit website.
患者来源的异种移植模型(PDXs)有潜力改变个性化癌症治疗,然而,对于使用PDXs指导治疗决策的可接受性知之甚少。鉴于患者和社区的偏好会影响对医疗服务的满意度以及新技术的成功应用,我们将评估PDXs在癌症患者个体及与社区对照中的可接受性。
这项比较性横断面研究将招募323名癌症患者(儿童期或成人期癌症幸存者以及儿童期癌症幸存者的父母)和323名社区对照者(成年人及父母)。我们将通过结构化访谈和问卷调查收集数据。为确定PDXs的可接受性,我们将评估五个领域:被诊断患有癌症时使用PDXs的意愿、PDXs的感知优势和劣势、每位患者可接受的最高自付费用、接收结果的可接受最长周转时间以及每位患者可接受的牺牲小鼠的最大数量。主要终点将是参与者的决策平衡比率(计算方法为参与者的优势评分除以感知劣势评分)。
本研究方案已获得悉尼东南部地方卫生区人类研究伦理委员会(HREC:12/173)和悉尼新南威尔士大学(HC15773)的批准。研究结果将在同行评审期刊和科学会议上发表。一份通俗易懂的总结将发布在行为科学部门的网站上。