Early Stage Breast CarcinomaNCT03003611
Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer
An observational study of Early Stage Breast Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Carcinoma
- What is being tested?
- hypnose sedation and general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Sep 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patient who will benefit of a surgery according a early stage of in-situ or infiltrated breast cancer
Who may be able to join
- Signed informed consent Form
- In situ breast cancer (early stage)
- Infiltrated Breast cancer (early stage)
Who cannot join
- No hypnoses is possible for this patient surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer
The investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose).
Patient will be informed that some parameters, about his recovery, will be collected from their medical file. They will not have another particular treatment because they are in the study. It is just a prospective data collection.
Read more
The patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) Also the investigators will compare the impact of hypnose on the other treatments the patient received.
The investigators need approximately 150 patients (Half in each arm).
- Conditions
- Early Stage Breast Carcinoma
- Being tested
- hypnose sedation, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnose sedationProcedure or surgery
Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
general anesthesiaProcedure or surgery
Patient will be anesthetized with a classical general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Hypnose | the group of patient who's operated under hypnose sedation Receives: Procedure: hypnose sedation | |
| traditional anesthesia | The match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery. Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
We'll collect the following information in the standard medical file :
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.
Items :
- Anxiety (will be mesured by the anxiety visual scale)
- Pain (mesured by analogic visual pain scale)
- consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
Measured: One day after the surgery
Secondary outcomes (2)
How is the recovering of the patient according his pain and anxiety, seven days after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
We'll collect the following information in the standard medical file :
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.
Items :
- Anxiety (will be mesured by the anxiety visual scale)
- Pain (mesured by analogic visual pain scale)
- consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
Measured: 7 days after surgery
Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)?
We'll collect the following information in the standard medical file :
- Redness of the skin : yes /no
- Delay in the scar process : yes/ no
- Infection: yes/ no
- Hypertrophie of the scar : yes/no
- Pain : Yes/No After analysis of the parameters, we will determine a good scar healing process, or not.
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Berlière, MD PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003611
- Sponsor's protocol ID
- ONCO-GYNECO 2014/1
- Status last verified
- Dec 2016
- First submitted
- 19 Jun 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berliere M, Roelants F, Watremez C, Docquier MA, Piette N, Lamerant S, Megevand V, Van Maanen A, Piette P, Gerday A, Duhoux FP. The advantages of hypnosis intervention on breast cancer surgery and adjuvant therapy. Breast. 2018 Feb;37:114-118. doi: 10.1016/j.breast.2017.10.017. Epub 2017 Nov 11.
PubMed 29136523
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer
- ClinicalTrials.gov ID
- NCT03003611
- Acronym / sponsor ID
- ONCO-GYNECO 2014/1
- Conditions
- Early Stage Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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 investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose).
Patient will be informed that some parameters, about his recovery, will be collected from their medical file. They will not have another particular treatment because they are in the study. It is just a prospective data collection.
The patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) Also the investigators will compare the impact of hypnose on the other treatments the patient received.
The investigators need approximately 150 patients (Half in each arm).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnose | – | Procedure: hypnose sedationthe group of patient who's operated under hypnose sedation |
| traditional anesthesia | – | Procedure: general anesthesiaThe match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who will benefit of a surgery according a early stage of in-situ or infiltrated breast cancer
Key inclusion criteria (3 listed)
- Signed informed consent Form
- In situ breast cancer (early stage)
- Infiltrated Breast cancer (early stage)
Key exclusion criteria (1 listed)
- No hypnoses is possible for this patient surgery
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 |
|---|---|---|
| hypnose sedationPatient will be anesthetized with an hypnose sedation and a complement with light anesthesia | Procedure or surgery | Hypnose |
| general anesthesiaPatient will be anesthetized with a classical general anesthesia | Procedure or surgery | traditional anesthesia |
Primary outcome
How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
Time frame: One day after the surgery
We'll collect the following information in the standard medical file : The collected measures who will analyzed are anxiety, pain and consumption of analgesic. Items : 1. Anxiety (will be mesured by the anxiety visual scale) 2. Pain (mesured by analogic visual pain scale) 3. consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
2 secondary outcomes
How is the recovering of the patient according his pain and anxiety, seven days after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
Time frame: 7 days after surgery
Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)?
Time frame: 7 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Derived from this study: PubMed 29136523Berliere M, Roelants F, Watremez C, Docquier MA, Piette N, Lamerant S, Megevand V, Van Maanen A, Piette P, Gerday A, Duhoux FP. The advantages of hypnosis intervention on breast cancer surgery and adjuvant therapy. Breast. 2018 Feb;37:114-118. doi: 10.1016/j.breast.2017.10.017. Epub 2017 Nov 11.
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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.
Martine Berlière, MD PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Stage Breast Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Nov 2017. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales. (time frame: One day after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003611, which also lists 1 linked publication.
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 13 Nov 2017.