Clinical trial · Observational

Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.

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.

NCT05447611CI-TRIAL-00059524EMPACOLnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Empathy	—	UNRESOLVED	—
Morality	—	UNRESOLVED	—
Morbidity	—	UNRESOLVED	—
Non-metastatic Colorectal Cancer	Colorectal Neoplasm	PROBABILISTIC	0.70
Quality of Life	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
high score CARE group
description
Patient-perceived empathy was assessed using the Consultation and Relational Empathy (CARE) questionnaire that has been validated in cancer care. This is a self-reported ten-point questionnaire with a five-point Likert-type scale ranging from "poor" to "excellent" Likert-type scale. It has excellent psychometric properties with α = 0.92. High scores indicate a higher perception of the health care personnel empathy. The three distinct empathic processes were also assessed with the CARE measure. 'Relationship' was assessed with items 1-3, 'emotional process' with items 4-6, and 'cognitive process' with items 7-10.
label
lower score CARE group
description
In line with the recent literature, we considered differentiating the study population into two groups: those with a high perceived empathy (maximum CARE score) and those without.

Primary outcomes (1)

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
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDMulliri A, Lelorain S, Bouvier V, Bara S, Gardy J, Grynberg D, Morello R, Alves A, Dejardin O. Role of empathy in the outcomes of colorectal cancer: protocol for a population-based study in two areas in France (EMPACOL Project). BMJ Open. 2022 Nov 29;12(11):e066559. doi: 10.1136/bmjopen-2022-066559. PMID 36446452