Well-being and Stress Control After Colorectal Surgery

Not Applicable

Recruiting

• Conditions: Patients with Colorectal Cancer; Surgery
• Interventions: Behavioral: Stress management sessions

• Registration Number: NCT03844347
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-18
• Study Start: 2019-10-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-Bien	Stress management sessions	-

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy Colorectal	5 days after surgery (the day of hospital leaving)	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
Manifestations of Psychological Well-being Measurement	5 days after surgery (the day of hospital leaving)	Patient general quality of life measurement

Secondary Outcome Measures

Name	Time	Method
Pain assessment	1 day after surgery up to 5 days after surgery (the day of hospital leaving)	Evaluation of the subjective pain sensation with the EVA score
Fatigue measure	1 day after surgery up to 5 days after surgery (the day of hospital leaving)	the BFI (Brief Fatigue Inventory) assess the physical and mental fatigue
Sleep quality assessment	1 day after surgery up to 5 days after surgery (the day of hospital leaving)	Assessed with the Pittsburgh Sleep Quality Index score
Physical activity evaluation	1 day after surgery up to 5 days after surgery (the day of hospital leaving)	Actimetric evaluation: measurement of sleep phases and number of steps (Actiwatch AW7)

Trial Locations

Locations (1)

University Hospital, Strasbourg, france; 🇫🇷 Strasbourg, France