Well-being and Stress Control After Colorectal Surgery

NCT03844347 | Terminated

• 1 other identifier: 7317
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients with Colorectal Cancer; Surgery

Keywords

Colorectal cancer; Well-being; Stress; Recovery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Fatigue measure

  7 days before surgery

• Fatigue measure

  5 days after surgery (the day of hospital leaving)

• Fatigue measure

  1 day after surgery up to 5 days after surgery (the day of hospital leaving)

• Sleep quality assessment

  7 days before surgery

• Sleep quality assessment

  1 day after surgery up to 5 days after surgery (the day of hospital leaving)

Study Arms (2)

C-Bien

EXPERIMENTAL

Behavioral: Stress management sessions

Control

NO INTERVENTION

Interventions

Stress management sessions BEHAVIORAL

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.

C-Bien

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing colorectal cancer surgery
• Regulated surgery
• With or without radiation treatment and / or preoperative chemotherapy.
• Patient benefiting from a social protection scheme

You may not qualify if:

• \-- 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Benoît ROMAIN, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 18, 2019
• Study Start: October 21, 2019
• Primary Completion: August 3, 2024
• Study Completion: September 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)