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Well-being and Stress Control After Colorectal Surgery

Well-being and Stress Control After Colorectal Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844347
Acronym
C-Bien
Enrollment
154
Registered
2019-02-18
Start date
2019-10-21
Completion date
2024-09-05
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Colorectal Cancer, Surgery

Keywords

Colorectal cancer, Well-being, Stress, Recovery

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.

Interventions

BEHAVIORALStress 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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Assessment of Cancer Therapy Colorectal7 days before surgeryThe 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 Measurement7 days before surgeryPatient general quality of life measurement

Secondary

MeasureTime frameDescription
Fatigue measure7 days before surgeryThe MFI (Multidimensional Inventory of Fatigue)
Sleep quality assessment7 days before surgeryAssessed with the Pittsburgh Sleep Quality Index score
Pain assessment7 days before surgeryEvaluation of the subjective pain sensation with the EVA score
Physical activity evaluation1 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026