Empathy, Morality, Morbidity, Non-metastatic Colorectal Cancer, Quality of Life
Conditions
Keywords
colorectal cancer, empathy, outcomes
Brief summary
The aim of project EMPACOL will be to investigate, while taking into consideration the clinical factors known and well described in the literature, among the non-clinical factors, in particular, patient-healthcare personnel (HCP) relationship, a link between HCP's empathy perceived by the patient, and the results of the curative treatment of non-metastatic colorectal cancer, throughout the patient's care.
Detailed description
EMPACOL will be a multicenter prospective longitudinal study. Over a 2-year period, in two French areas covered by a cancer register, 8 centers will include patients with non-metastatic CRC, uncomplicated at diagnosis Based on the curative treatment strategy, patients will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy), group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy). The relationship between HCP's empathy, perceived by the patient, after 2 years of inclusion, and the quality of life (QoL) at one year after the end of treatment will be investigated. QoL will be investigated using the QLQ C-30 questionnaire. Finally, a link between PHC perception and oncological outcomes will be sought.
Interventions
None listed
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Patients aged 18 to 75 years, French-speaking, affiliated to a social security system, having received informed information and not having expressed an unfavorable opinion to participate; carriers of non-metastatic and uncomplicated CRC (without occlusion/ perforation/bleeding), requiring elective therapeutic management. The included patients have a cognitive state capable of understanding and completing the questionnaires (autonomous completion).
Exclusion criteria
Patients who were minors or older than 80 years, residing in a department outside Calvados or Manche, presenting a CRC other than adenocarcinoma and all metastatic forms or requiring emergency surgery (perforation, hemorrhage, occlusion), exclusive endoscopic treatment, or a missed-CRC discovered after surgery for non-oncological indications. Patients with another neoplastic disease under treatment and/or evolving, patients with a history of inflammatory bowel disease (Crohn's disease, ulcerative colitis) and/or hereditary disease predisposing to CRC (Lynch syndrome, familial polyposis) or with severe cognitive impairment preventing proper comprehension of the questionnaires. Pregnant women will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main objective of the EMPACOL project is to investigate, in non-metastatic CRC patients, a possible correlation, between perceived HCP's empathy and survival (OS and DFS). | 5 years of follow up | Based on the curative treatment strategy, patients with non-metastatic CRC will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy), group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy). The relationship between patient-perceived HCP empathy after 2 years of inclusion and 5-year survival will be studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relationship between caregiver empathy, as perceived by the patient, and quality of life (QoL) will be studied. | One year after the end of treatment | Quality of life will be studied using the QLQ C-30 questionnaire. |
Outcome results
None listed