EMPACOL: Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| high score CARE group 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. |
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| lower score CARE group 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. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Caen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-0065