Well-being and Stress Control After Colorectal Surgery (C-Bien)

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Surgery; Patients with Colorectal Cancer

Treatments: Behavioral: Stress management sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03844347

7317

Details and patient eligibility

About

The criteria usually considered to evaluate the quality of life are the presence or absence of a stomy, alteration of the transit or the sexual dysfunctions. Quality of life has been improved by introducing an Enhanced Postoperative Rehabilitation Program After Surgery (ERAS). It is a multidisciplinary medical and paramedical care aimed at minimizing the sources of stress allowing a significant reduction in postoperative complications and length of stay.

However, the emotional feelings of patients, their fatigue, the quality of their relationships with others and their experience of the disease are not usually considered. Nevertheless, these criteria influence the quality of life and constitute the fundamental bases of the psychological well-being, essential in the recovery processes.

We propose to enrich the ERAS program by introducing an individualized support of well-being and stress management aimed at increasing the quality of life of patients. The purpose is to make the patient more autonomous by allowing him/her, to implement stress management exercises.

The main goal of the project is to improve the psychological well-being of patients operated on for colorectal cancer by offering stress management sessions in order to promote postoperative rehabilitation.

The secondary objectives are to demonstrate the impact of stress management sessions on the length of stay and to study the link between the efficiency of these sessions and the quality of life of patients before the surgery.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing colorectal cancer surgery
• Regulated surgery
• With or without radiation treatment and / or preoperative chemotherapy.
• Patient benefiting from a social protection scheme

Exclusion criteria

-- Limitation of linguistic or cognitive abilities interfering with the understanding of the study protocol

• Absence of the consent form of the study
• Emergency surgery
• Stomy closure
• Patient diagnosed psychotic.
• Patient with "psychiatric disorder" left to the discretion of the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

C-Bien

Experimental group

Treatment:

Behavioral: Stress management sessions

Control

No Intervention group