Clinical trial NCT05447611: Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.
Official title: Role of Empathy in the Outcome of Curative Treatment of Non-metastatic Colorectal Cancer. Prospective Multicenter Longitudinal Study in Two Departments Covered by the Calvados Cancer Registry.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-metastatic Colorectal Cancer
Empathy
Morbidity
Morality
Quality of Life
Keywords: colorectal cancer
empathy
outcomes
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical information included gender, age, obesity, active smoking and alcohol use alcohol , the ASA physical status classification system (I-II versus III-IV), anxious and depressive states (HADS score) of patient and presentation at multidisciplinary consultation, histology and tumor differentiation, surgical approach, as well as neoadjuvant or adjuvant treatments (type and number of sessions), site of the primary tumor (colon vs rectum). The forms located at the rectosigmoid junction were included in the colonic localizations.

All patients diagnosed with CRC during the inclusion period were included in two specialized digestive cancer registries of North-West France, members of the French network of cancer registries (FRANCIM), department of Calvados and Manche.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 5 years of follow up
Secondary outcomes:
measure: The relationship between caregiver empathy, as perceived by the patient, and quality of life (QoL) will be studied.
timeFrame: One year after the end of treatment
Other outcomes:
Locations:
Study officials:
References: