Protocol of a randomized controlled trial evaluating program facilitating empathetic communication for initiating advanced care planning discussions between patients with advanced cancer and healthcare providers (J-SUPPORT 2104)

IntroductionIn patients with incurable advanced cancer, preferences about treatment and how to spend their final days are not adequately discussed. This process of discussion is called "advanced care planning" (ACP), and timely intervention is recommended. As the communication attitude of healthcare providers is a critical factor in ACP facilitation, improving their communication attitudes may reduce patient distress, improve care satisfaction, and reduce unnecessarily aggressive treatment. Digital mobile devices are being developed for behavioral interventions due to their low space and time restrictions, and the ease of sharing information. The purpose of this study is to evaluate the effectiveness of a facilitation program utilizing a mobile app developed to improve communication between cancer patients and healthcare providers regarding ACP. Methods and analysisThis study utilizes a parallel-group, evaluator-blind, randomized controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer. Intervention group participants will use a mobile app ACP program and undergo a 30-minute interview with a trained intervention provider to discuss with the oncologist at the next patient visit. Control group participants will continue their usual treatment. The primary outcome is the oncologists communication behavior score assessed using audio recordings of the consultation. The secondary outcomes include communication between patients and oncologists and the patients distress, quality of life, care goals and preferences, and medical care utilization. We will use a full analysis set with the registered participant population who received at least a part of the intervention. Ethics and disseminationThe 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 Center Hospital (registration No. 2020-500). The results of the RCT will be published in peer-reviewed scientific journals and presented at scientific meetings. Strengths and limitations of this studyO_LIRandomized controlled trials using mobile apps for behavior change and psychological interventions are increasing, and this study is unique in its focus on facilitating communication about advanced care planning (ACP). C_LIO_LIThe intervention will include mobile apps which can be used in environments the participants find relaxing and engaging. The benefit is particularly significant for patients with advanced cancer who need to express their values and what is crucial to them. C_LIO_LIThere is currently no gold standard for evaluating ACP discussions between patients and healthcare providers. The methods facilitate ACP discussions in various aspects of this study to produce a variety of practical insights. C_LIO_LIThe timing of introducing ACP discussions must be individualized to each patient, and it is anticipated that some participants may find this intervention burdensome. Therefore, more careful ACP referrals are needed, and qualitative exploration of study dropouts is needed. C_LIO_LIMultiple intervention components make it difficult to determine which is most effective. Individualized assessments of app usage, intervention adherence, and patient satisfaction could clarify the challenges and help determine next steps. C_LI