Clinical trial NCT03844347: Well-being and Stress Control After Colorectal Surgery
Official title: Well-being and Stress Control After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients with Colorectal Cancer
Surgery
Keywords: Colorectal cancer
Well-being
Stress
Recovery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy Colorectal
timeFrame: 7 days before surgery
measure: Functional Assessment of Cancer Therapy Colorectal
timeFrame: 5 days after surgery (the day of hospital leaving)
measure: Manifestations of Psychological Well-being Measurement
timeFrame: 7 days before surgery
measure: Manifestations of Psychological Well-being Measurement
timeFrame: 5 days after surgery (the day of hospital leaving)
Secondary outcomes:
measure: Fatigue measure
timeFrame: 7 days before surgery
measure: Fatigue measure
timeFrame: 5 days after surgery (the day of hospital leaving)
measure: Fatigue measure
timeFrame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
measure: Sleep quality assessment
timeFrame: 7 days before surgery
measure: Sleep quality assessment
timeFrame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
measure: Pain assessment
timeFrame: 7 days before surgery
measure: Pain assessment
timeFrame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
measure: Physical activity evaluation
timeFrame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Benoît ROMAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: