Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial

Abstract

IntroductionCommunication is an essential aspect of care for patients with progressive serious illnesses. This study aims to evaluate the efficacy of a new, integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers.Methods and analysisThe proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospitals in a metropolitan area in Japan. A total of 20 oncologists, 200 patients with advanced pancreatic cancer and the patients’ caregivers are enrolled in this study as of the writing of this protocol report. Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients and caregivers are allocated to the same group as their oncologists. The IG oncologists receive a 2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training. Follow-up data will be collected quarterly for 6 months for a year and then annually for up to 3 years. The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.Ethics and disseminationThis study is conducted in accordance with the ethical guidelines for clinical studies published by Japan’s Ministry of Education, Cultural, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of National Cancer Center, Japan on 4 July 2018 (ID: 2017-474).Trial statusThis study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023.Trial registration numberUMIN Clinical Trial Registry (UMIN000033612); pre-results.

Geriatric assessment and management with question prompt list using a web-based application for elderly patients with cancer (MAPLE) to communicate ageing-related concerns: J-SUPPORT 2101 study protocol for a multicentre, parallel group, randomised controlled trial

“…In this study, a QPL that was developed based on our previous studies19 28 29 to support shared decision-making for treatment of elderly patients with cancer will be used to facilitate communications with attending oncologists. The QPL consists of 75 questions categorised into 8 topics and a free-writing section for other ageing-related questions based on the opinions of elderly patients with cancer, oncologists and geriatricians (table 4).…”

Effectiveness of communication skill training on cancer truth‐telling for advanced practice nurses in Taiwan: A pilot study

“…Additionally, we enrolled patients and their caregivers to test the effectiveness of the CST from the recipients' viewpoint. Based on a previous study, 7–10 patients per trainee would be required in the follow‐up phase 32 . Thus, a total of 364–520 pairs of patients and caregivers were required.…”

“…Based on a previous study, 7-10 patients per trainee would be required in the follow-up phase. 32 Thus, a total of 364-520 pairs of patients and caregivers were required. However, due to a 25% refusal rate, only 240 pairs of patients and caregivers participated and completed data collection.…”

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)

“…We previously developed a face-to-face behavioral intervention program using QPL and CST to improve the introduction of ACP discussion between healthcare providers and their cancer patients being given bad news. [21] Combining a 2.5 hr individualized communication skills training for healthcare providers with a 30 min coaching intervention for patients, we found statistically significant improvements in empathic communication and information sharing among healthcare providers. In addition, patients in the intervention group were more satisfied with the consultation.…”

“…In addition, patients in the intervention group were more satisfied with the consultation. [21 22] However, from the perspective of implementing a communication intervention, face-to-face programs held in hospitals could create significant time and space burdens for both patients and healthcare providers.…”