A randomized controlled trial with a cluster of oncologists evaluating of an integrated communication support program for oncologists, caregivers, and patients with rapidly progressing advanced cancer on patient-centered conversation: J-SUPPORT 1704 study.
Authors: Fujimori Maiko , Sato Ayako , Okusaka Takuji , Yamaguchi Takuhiro , Ikeda Masafumi , Ueno Makoto , Ozaka Masato , Miyaji Tempei , Mashiko Tomoe , Okamura Masako , Goto Shinichi , Majima Yoshiyuki , Uchitomi Yosuke 
Published: June 2021

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Background: Communication is an essential aspect of care for patients with progressive serious illnesses. Earlier discussion about patients’ values and priorities may lead to empathic communication and more goal-concordant care, and improved quality of life (QOL). This study aims to evaluate the efficacy of a newly developed integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers. Methods: Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients with advanced pancreatic cancer after the start of first-line chemotherapy and their 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 prioritizing and discussing questions and concerns about care after standard chemotherapy; the CG participants do not receive any training. Conversations during the post-intervention consultation between oncologists, patients and caregivers were audio-recorded, and were assessed on their empathic communication and information sharing performance as primary outcome. Secondary outcomes included the patient psychological distress (HADS), QOL (CoQOLo), satisfaction with communication (CSQ) and trust in oncologist (TiOS) were assessed baseline and after the consultation. Results: A total of 26 oncologists (12 intervention; 13 control; 1 excluded before randomization), 230 patients (115 intervention; 115 control), and 127 caregivers (65 intervention; 62 control) in 4 teaching hospitals are enrolled. The intervention resulted statistically significant improvements in the empathetic communication (IG: Mean = 23.4, Standard Error = 0.8; CG: M = 20.3, SE = 0.7; effect, 3.1; 95%CI, 1.0-5.3; P = 0.0063) and in the information sharing (IG: M = 17.6, SE = 0.8; CG: M = 13.2, SE = 0.5; effect, 4.4; 95%CI, 2.5-6.2; P < 0.0001). Patients in IG rated more satisfaction with communication using CSQ (effect, 2.4; 95%CI, 1.3, 3.5; P = 0.00023) than those in the CG. There were no differences in HADS total score (effect, 0.1; 95%CI, -1.0, 1.1; P = 0.90), CoQOLo score (effect, 0.4; 95%CI, -0.7, 1.4; P = 0.46) and TiOS score (effect, 0.2; 95%CI, -0.1, 0.6; P = 0.15) between patients in the IG and the CG. Conclusions: The program for oncologist and patients with rapidly progressing advanced cancer was effective in improving empathic communication and information sharing about care after standard chemotherapy, and patients’ reported satisfaction with communication without increasing psychological distress, but did not affect QOL and trust in oncologists immediately after the consultation. Clinical trial information: UMIN000033612.