Role of empathy in the outcomes of colorectal cancer: protocol for a population-based study in two areas in France (EMPACOL Project). Issue 11 (29th November 2022)

• Record Type: Journal Article
• Authors: Mulliri, Andrea; Lelorain, Sophie; Bouvier, Véronique; Bara, Simona; Gardy, Josephine; Grynberg, Delphine; Morello, Rémy; Alves, Arnaud; Dejardin, Olivier
• Is Part Of: BMJ open. Volume 12:Issue 11(2022)
• Publication Date: 2022-11-29
• Subjects: Gastrointestinal tumours -- Quality in health care -- Colorectal surgery; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-066559
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: The EMPACOL Project aims to investigate the link between healthcare professionals' (HCPs) empathy and the results of the curative treatment of non-metastatic colorectal cancer (CRC). Methods and analysis: EMPACOL will be an observational multicentric prospective longitudinal study. It will cover eight centres comprising patients with non-metastatic CRC, uncomplicated at diagnosis in two French areas covered by a cancer register over a 2-year period. As estimated by the two cancer registries, during the 2-year inclusion period, the number of cases of non-metastatic CRCs was approximately 480. With an estimated participation rate of about 50%, we expect around 250 patients will be included in this study. Based on the curative strategy, patients will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy) and group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy). The relationship between HCPs' empathy at the time of announcement and at the end of the strategy, quality of life (QoL) 1 year after the end of treatment and oncological outcomes after 5 years will be investigated. HCPs' empathy and QoL will be assessed using the patient-reported questionnaires, Consultation and Relational Empathy and European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire, respectively. A relationship between HCPs' empathy and early outcomes, particularly digestive and genitourinary sequelae, will also be studied for each treatment group. Post-treatment complications will be assessed using the Clavien-Dindo classification. Patients' anxiety and depression will also be assessed using the Hospital Anxiety and Depression Scale questionnaire. Ethics and dissemination: The Institutional Review Board of the University Hospital of Caen and the Ethics Committee (ID RCB: 2022-A00628-35) have approved the study. Patients will be required to provide oral consent for participation. Results of this study will be disseminated by publication in peer-reviewed journals. Trial registration number: NCT05447611 .