Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan.
Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan
BMJ Open. 2023 Mar 28;13(3):e069557. doi: 10.1136/bmjopen-2022-069557.
Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.
This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist's communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients' distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.
The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.
UMIN000045305, NCT05045040.
建议及时进行预先医疗照护计划（ACP）的讨论过程。医疗保健提供者的沟通态度在 ACP 促进中至关重要；因此，改善他们的沟通态度可能会减少患者的痛苦和不必要的激进治疗，同时提高护理满意度。由于数字移动设备具有空间和时间限制低以及易于信息共享的特点，因此正在开发用于行为干预的数字移动设备。本研究旨在评估使用旨在促进患者提问行为的应用程序的干预计划在改善晚期癌症患者与医疗保健提供者之间的 ACP 相关沟通方面的效果。
本研究采用平行组、评估者盲法、随机对照试验设计。我们计划在日本东京的国立癌症中心招募 264 名患有不治之症的晚期癌症成年患者。干预组参与者使用移动应用程序 ACP 计划，并接受经过培训的干预提供者进行 30 分钟的访谈，以便在下一次患者就诊时与肿瘤医生进行讨论，而对照组参与者则继续接受常规治疗。主要结局是使用咨询的录音评估肿瘤医生的沟通行为评分。次要结局包括患者与肿瘤医生之间的沟通以及患者的痛苦、生活质量、护理目标和偏好以及医疗保健的使用情况。我们将使用全分析集，包括接受至少部分干预的登记参与者人群。
该研究方案已由日本支持性、姑息性和心理肿瘤学小组的科学咨询委员会（注册号 2104）和国家癌症中心医院的机构审查委员会（注册号 2020-500）审查和批准。从患者处获得书面知情同意。试验结果将发表在同行评议的科学期刊上，并在科学会议上展示。
UMIN000045305，NCT05045040。
