Well-being and Stress Control After Colorectal Surgery (C-Bien)
Primary Purpose
Patients With Colorectal Cancer, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress management sessions
Sponsored by
About this trial
This is an interventional other trial for Patients With Colorectal Cancer focused on measuring Colorectal cancer, Well-being, Stress, Recovery
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
Sites / Locations
- University Hospital, Strasbourg, franceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
C-Bien
Control
Arm Description
Outcomes
Primary Outcome Measures
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
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
Manifestations of Psychological Well-being Measurement
Patient general quality of life measurement
Manifestations of Psychological Well-being Measurement
Patient general quality of life measurement
Secondary Outcome Measures
Fatigue measure
The MFI (Multidimensional Inventory of Fatigue)
Fatigue measure
The MFI (Multidimensional Inventory of Fatigue)
Fatigue measure
the BFI (Brief Fatigue Inventory) assess the physical and mental fatigue
Sleep quality assessment
Assessed with the Pittsburgh Sleep Quality Index score
Sleep quality assessment
Assessed with the Pittsburgh Sleep Quality Index score
Pain assessment
Evaluation of the subjective pain sensation with the EVA score
Pain assessment
Evaluation of the subjective pain sensation with the EVA score
Physical activity evaluation
Actimetric evaluation: measurement of sleep phases and number of steps (Actiwatch AW7)
Full Information
NCT ID
NCT03844347
First Posted
February 11, 2019
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03844347
Brief Title
Well-being and Stress Control After Colorectal Surgery
Acronym
C-Bien
Official Title
Well-being and Stress Control After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Colorectal Cancer, Surgery
Keywords
Colorectal cancer, Well-being, Stress, Recovery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-Bien
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stress management sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy Colorectal
Description
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
Time Frame
7 days before surgery
Title
Functional Assessment of Cancer Therapy Colorectal
Description
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
Time Frame
5 days after surgery (the day of hospital leaving)
Title
Manifestations of Psychological Well-being Measurement
Description
Patient general quality of life measurement
Time Frame
7 days before surgery
Title
Manifestations of Psychological Well-being Measurement
Description
Patient general quality of life measurement
Time Frame
5 days after surgery (the day of hospital leaving)
Secondary Outcome Measure Information:
Title
Fatigue measure
Description
The MFI (Multidimensional Inventory of Fatigue)
Time Frame
7 days before surgery
Title
Fatigue measure
Description
The MFI (Multidimensional Inventory of Fatigue)
Time Frame
5 days after surgery (the day of hospital leaving)
Title
Fatigue measure
Description
the BFI (Brief Fatigue Inventory) assess the physical and mental fatigue
Time Frame
1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Title
Sleep quality assessment
Description
Assessed with the Pittsburgh Sleep Quality Index score
Time Frame
7 days before surgery
Title
Sleep quality assessment
Description
Assessed with the Pittsburgh Sleep Quality Index score
Time Frame
1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Title
Pain assessment
Description
Evaluation of the subjective pain sensation with the EVA score
Time Frame
7 days before surgery
Title
Pain assessment
Description
Evaluation of the subjective pain sensation with the EVA score
Time Frame
1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Title
Physical activity evaluation
Description
Actimetric evaluation: measurement of sleep phases and number of steps (Actiwatch AW7)
Time Frame
1 day after surgery up to 5 days after surgery (the day of hospital leaving)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît ROMAIN, MD
Phone
03 88 12 72 43
Ext
0033
Email
benoit.romain@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît ROMAIN, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit ROMAIN, MD
Email
benoit.romain@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Well-being and Stress Control After Colorectal Surgery
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