Well-being and Stress Control After Colorectal Surgery

Surgery Clinical Trial

— C-Bien  

Official title:

Well-being and Stress Control After Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844347
• Other study ID #: 7317
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Benoît ROMAIN, MD
• Phone: 03 88 12 72 43
• Email: benoit.romain[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Patients With Colorectal Cancer
• Surgery

Intervention

Behavioral:
• Stress management sessions
Stress management sessions are proposed to the patients and consist of small exercises focused on breathing and bodily sensations. Each accompanying person has access to different exercises. The sessions are adapted to the state of the patient to promote his well-being, before or after his/her operation. The duration of a preoperative session is 1 hour, the duration of the postoperative sessions is 15 minutes.

Locations

Country	Name	City	State
France	University Hospital, Strasbourg, france	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy Colorectal	The general well-being questionnaire (FACTC), validated with patients with colorectal cancer, which will allow us to measure the subjective feelings (physical, emotional and social well-being) of patients before hospitalization and on leaving the hospital	7 days before surgery
Primary	Functional Assessment of Cancer Therapy Colorectal	The general well-being questionnaire (FACTC), validated with patients with colorectal cancer, which will allow us to measure the subjective feelings (physical, emotional and social well-being) of patients before hospitalization and on leaving the hospital	5 days after surgery (the day of hospital leaving)
Primary	Manifestations of Psychological Well-being Measurement	Patient general quality of life measurement	7 days before surgery
Primary	Manifestations of Psychological Well-being Measurement	Patient general quality of life measurement	5 days after surgery (the day of hospital leaving)
Secondary	Fatigue measure	The MFI (Multidimensional Inventory of Fatigue)	7 days before surgery
Secondary	Fatigue measure	The MFI (Multidimensional Inventory of Fatigue)	5 days after surgery (the day of hospital leaving)
Secondary	Fatigue measure	the BFI (Brief Fatigue Inventory) assess the physical and mental fatigue	1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Secondary	Sleep quality assessment	Assessed with the Pittsburgh Sleep Quality Index score	7 days before surgery
Secondary	Sleep quality assessment	Assessed with the Pittsburgh Sleep Quality Index score	1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Secondary	Pain assessment	Evaluation of the subjective pain sensation with the EVA score	7 days before surgery
Secondary	Pain assessment	Evaluation of the subjective pain sensation with the EVA score	1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Secondary	Physical activity evaluation	Actimetric evaluation: measurement of sleep phases and number of steps (Actiwatch AW7)	1 day after surgery up to 5 days after surgery (the day of hospital leaving)