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

NCT05447611 | Not Yet Recruiting

• 1 other identifier: 22-0065
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-metastatic Colorectal Cancer; Empathy; Morbidity; Morality; Quality of Life

Keywords

colorectal cancer; empathy; outcomes

Outcome Measures

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.

  5 years of follow up

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Related Publications (1)

• Mulliri 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 7, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share