Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity Hospital, Caen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: high score CARE group
Group B: lower score CARE group
Trial outcomes
Primary outcomes
1
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).
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.
Time frame
5 years of follow upSecondary outcomes
1
The relationship between caregiver empathy, as perceived by the patient, and quality of life (QoL) will be studied.
Quality of life will be studied using the QLQ C-30 questionnaire.
Time frame
One year after the end of treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: