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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Patients With Colorectal Cancer
• Intervention / Treatment: Behavioral: Stress management sessions

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benoît ROMAIN, MD; Phone Number: 0033 03 88 12 72 43; Email: benoit.romain@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • University Hospital, Strasbourg, France
    • Contact: Benoit ROMAIN, MD; Email: benoit.romain@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: C-Bien	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Manifestations of Psychological Well-being Measurement	Patient general quality of life measurement	7 days before surgery
Manifestations of Psychological Well-being Measurement	Patient general quality of life measurement	5 days after surgery (the day of hospital leaving)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue measure	The MFI (Multidimensional Inventory of Fatigue)	7 days before surgery
Fatigue measure	The MFI (Multidimensional Inventory of Fatigue)	5 days after surgery (the day of hospital leaving)
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)
Sleep quality assessment	Assessed with the Pittsburgh Sleep Quality Index score	7 days before surgery
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)
Pain assessment	Evaluation of the subjective pain sensation with the EVA score	7 days before surgery
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Benoît ROMAIN, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Recovery; Stress; Colorectal cancer; Well-being
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 7317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No