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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05447611
Other study ID # 22-0065
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2022
Est. completion date September 2029

Study information

Verified date June 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date September 2029
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
5 years of follow up
Secondary 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. One year after the end of treatment
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