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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: INTRODUCTION:Communication 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 ANALYSIS:The 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 DISSEMINATION:This 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 STATUS:This study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023. TRIAL REGISTRATION NUMBER:UMIN Clinical Trial Registry (UMIN000033612); pre-results.

SUBMITTER: Fujimori M

PROVIDER: S-EPMC7513597 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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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.

Fujimori Maiko M Sato Ayako A Jinno Sayaka S Okusaka Takuji T Yamaguchi Takuhiro T Ikeda Masafumi M Ueno Makoto M Ozaka Masato M Takayama Yukiko Y Miyaji Tempei T Majima Yoshiyuki Y Uchitomi Yosuke Y

BMJ open 20200923 9

<h4>Introduction</h4>Communication 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.<h4>Methods and analysis</h4>The proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospita ...[more]

PMID: 32967874

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Project description:BackgroundQuality cancer care requires addressing patients' emotions, which oncologists infrequently do. Multiday courses can teach oncologists skills to handle emotion; however, such workshops are long and costly.ObjectiveTo test whether a brief, computerized intervention improves oncologist responses to patient expressions of negative emotion.DesignRandomized, controlled, parallel-group trial stratified by site, sex, and oncologic specialty. Oncologists were randomly assigned to receive a communication lecture or the lecture plus a tailored CD-ROM. (ClinicalTrials.gov registration number: NCT00276627)SettingOncology clinics at a comprehensive cancer center and Veterans Affairs Medical Center in Durham, North Carolina, and a comprehensive cancer center in Pittsburgh, Pennsylvania.Participants48 medical, gynecologic, and radiation oncologists and 264 patients with advanced cancer.InterventionOncologists were randomly assigned in a 1:1 ratio to receive an interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.MeasurementsPostintervention audio recordings were used to identify the number of empathic statements and responses to patients' expressions of negative emotion. Surveys evaluated patients' trust in their oncologists and perceptions of their oncologists' communication skills.ResultsOncologists in the intervention group used more empathic statements (relative risk, 1.9 [95% CI, 1.1 to 3.3]; P = 0.024) and were more likely to respond to negative emotions empathically (odds ratio, 2.1 [CI, 1.1 to 4.2]; P = 0.028) than control oncologists. Patients of intervention oncologists reported greater trust in their oncologists than did patients of control oncologists (estimated mean difference, 0.1 [CI, 0.0 to 0.2]; P = 0.036). There was no significant difference in perceptions of communication skills.LimitationsLong-term effects were not examined. The findings may not be generalizable outside of academic medical centers.ConclusionA brief computerized intervention improves how oncologists respond to patients' expressions of negative emotions.Primary funding sourceNational Cancer Institute.

Project description:BackgroundSudden unexpected death in epilepsy (SUDEP) is a rare but fatal risk that patients, parents, and professional societies clearly recommend discussing with patients and families. However, this conversation does not routinely happen.ObjectivesThis pilot study aimed to demonstrate whether computerized decision support could increase patient communication about SUDEP.MethodsA prospective before-and-after study of the effect of computerized decision support on delivery of SUDEP counseling. The intervention was a screening, alerting, education, and follow-up SUDEP module for an existing computerized decision support system (the Child Health Improvement through Computer Automation [CHICA]) in five urban pediatric primary care clinics. Families of children with epilepsy were contacted by telephone before and after implementation to assess if the clinician discussed SUDEP at their respective encounters.ResultsThe CHICA-SUDEP module screened 7,154 children age 0 to 21 years for seizures over 7 months; 108 (1.5%) reported epilepsy. We interviewed 101 families after primary care encounters (75 before and 26 after implementation) over 9 months. After starting CHICA-SUDEP, the number of caregivers who reported discussing SUDEP with their child's clinician more than doubled from 21% (16/75) to 46% (12/26; p = 0.03), and when the parent recalled who brought up the topic, 80% of the time it was the clinician. The differences between timing and sampling methodologies of before and after intervention cohorts could have led to potential sampling and recall bias.ConclusionClinician-family discussions about SUDEP significantly increased in pediatric primary care clinics after introducing a systematic, computerized screening and decision support module. These tools demonstrate potential for increasing patient-centered education about SUDEP, as well as incorporating other guideline-recommended algorithms into primary and subspecialty cares.Clinical trial registrationclinicaltrials.gov, NCT03502759.

Dataset Information

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.

Publications

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.

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