Patients with Colorectal CancerC-BienNCT03844347
Well-being and Stress Control After Colorectal Surgery
A study testing Stress management sessions in people with Patients with Colorectal Cancer and Surgery, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients with Colorectal Cancer, Surgery
- What is being tested?
- Stress management sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing colorectal cancer surgery
- Regulated surgery
- With or without radiation treatment and / or preoperative chemotherapy.
- Patient benefiting from a social protection scheme
Who cannot join
- -- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Stress management sessions
- Keywords
- Colorectal cancer, Well-being, Stress, Recovery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress management sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| C-Bien | Experimental | Not described Receives: Behavioral: Stress management sessions |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 days after surgery (the day of hospital leaving)
Manifestations of Psychological Well-being Measurement
Patient general quality of life measurement
Measured: 7 days before surgery
Manifestations of Psychological Well-being Measurement
Patient general quality of life measurement
Measured: 5 days after surgery (the day of hospital leaving)
Secondary outcomes (8)
Fatigue measure
The MFI (Multidimensional Inventory of Fatigue)
Measured: 7 days before surgery
Fatigue measure
The MFI (Multidimensional Inventory of Fatigue)
Measured: 5 days after surgery (the day of hospital leaving)
Fatigue measure
the BFI (Brief Fatigue Inventory) assess the physical and mental fatigue
Measured: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Sleep quality assessment
Assessed with the Pittsburgh Sleep Quality Index score
Measured: 7 days before surgery
Sleep quality assessment
Assessed with the Pittsburgh Sleep Quality Index score
Measured: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Pain assessment
Evaluation of the subjective pain sensation with the EVA score
Measured: 7 days before surgery
Pain assessment
Evaluation of the subjective pain sensation with the EVA score
Measured: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Physical activity evaluation
Actimetric evaluation: measurement of sleep phases and number of steps (Actiwatch AW7)
Measured: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start21 Oct 2019
- Primary completion3 Aug 2024
- Study completion5 Sep 2024
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît ROMAIN, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844347
- Sponsor's protocol ID
- 7317
- Acronym
- C-Bien
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-being and Stress Control After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03844347
- Acronym / sponsor ID
- C-Bien / 7317
- Conditions
- Patients with Colorectal Cancer, Surgery
- Keywords
- Colorectal cancer, Well-being, Stress, Recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Bien | Experimental | Behavioral: Stress management sessions |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing colorectal cancer surgery
- Regulated surgery
- With or without radiation treatment and / or preoperative chemotherapy.
- Patient benefiting from a social protection scheme
Key exclusion criteria (6 listed)
- -- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress management sessionsStress 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. | Behavioural | C-Bien |
Primary outcome
Functional Assessment of Cancer Therapy Colorectal
Time frame: 7 days before surgery
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
Time frame: 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
Time frame: 7 days before surgery
Patient general quality of life measurement
Manifestations of Psychological Well-being Measurement
Time frame: 5 days after surgery (the day of hospital leaving)
Patient general quality of life measurement
8 secondary outcomes
Fatigue measure
Time frame: 7 days before surgery
Fatigue measure
Time frame: 5 days after surgery (the day of hospital leaving)
Fatigue measure
Time frame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Sleep quality assessment
Time frame: 7 days before surgery
Sleep quality assessment
Time frame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Pain assessment
Time frame: 7 days before surgery
Pain assessment
Time frame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Physical activity evaluation
Time frame: 1 day after surgery up to 5 days after surgery (the day of hospital leaving)
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît ROMAIN, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress management sessions in people with Patients with Colorectal Cancer and Surgery, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy Colorectal (time frame: 7 days before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.