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

NCT ID: NCT05447611

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2029-09-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 36446452 (View on PubMed)

Other Identifiers

22-0065

Identifier Type: -

Identifier Source: org_study_id