Breast CancerHYCOREMANCT02867644
Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer
A study of Breast Cancer, run by Institut de Cancérologie de Lorraine at 7 sites in France.
Trial summary
The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 7 sitesFrance
- Study dates
- 17 Nov 2016to 16 Oct 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patient undergoing for a preoperative breast assessment
- Patient must be affiliated to a social security system
- Ability to provide an informed written consent form
Who cannot join
- Patients diagnosed with major hearing loss
- Patients with schizophrenia
- Patients do not understand the French language
- Pregnant or breast feeding females
- Refusal of the patient to participate in the study
- Persons deprived of liberty or under supervision
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH Bastia
Bastia, 20600
Chu Bordeaux-Pellegrin
Bordeaux
CHRU de Brest
Brest
Centre Léon Bérard
Lyon
APHM La Timone
Marseille
Centre Paul Strauss
Strasbourg, 67065
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care
- Conditions
- Breast Cancer
- Being tested
- standard care, standard care + conversational hypnosis
- Keywords
- conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
Patients coming for preoperative breast assessment will have standard care.
standard care + conversational hypnosisOther
Patients coming for preoperative breast assessment will have standard care with conversational hypnosis
| Study group | Role | What they receive |
|---|---|---|
| standard care | Active comparator | Not described Receives: Other: standard care |
| standard care+conversational hypnosis | Experimental | Not described Receives: Other: standard care + conversational hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
Measured: Day 1
Secondary outcomes (4)
Compare the pain felt by patients during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
The pain level will be assessed in each group by a visual analog scale from 0 to 10.
Measured: Day 1
Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.
Measured: Day 1
Evaluate the receptivity of women to conversational hypnosis
assessment realisation time flet by patient
Measured: Day 1
Assess the impact of conversational hypnosis on completion of the examination
The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start17 Nov 2016
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Why it stopped: Results not achievable after interim analysis conclusions and recruting difficulty
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 Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HENROT Philippe, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867644
- Sponsor's protocol ID
- 2016-A00232-49
- Acronym
- HYCOREMA
- Status last verified
- Dec 2022
- First submitted
- 11 Aug 2016
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lemoine L, Adam V, Galus X, Siles P, Coulon A, Grenier-Desforges J, Orabona J, Kergastel I, Wagner P, Salleron J, Tosti P, Huin-Schohn C, Merlin JL, Etienne R, Henrot P. Conversational hypnosis versus standard of care to reduce anxiety in patients undergoing marker placement under radiographic control prior to breast cancer surgery: A randomized, multicenter trial. Front Psychol. 2022 Nov 22;13:971232. doi: 10.3389/fpsyg.2022.971232. eCollection 2022.
PubMed 36483698
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
- ClinicalTrials.gov ID
- NCT02867644
- Acronym / sponsor ID
- HYCOREMA / 2016-A00232-49
- Conditions
- Breast Cancer
- Keywords
- conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results not achievable after interim analysis conclusions and recruting difficulty
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 16 Aug 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 hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Active comparator | Other: standard care |
| standard care+conversational hypnosis | Experimental | Other: standard care + conversational hypnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patient undergoing for a preoperative breast assessment
- Patient must be affiliated to a social security system
- Ability to provide an informed written consent form
Key exclusion criteria (6 listed)
- Patients diagnosed with major hearing loss
- Patients with schizophrenia
- Patients do not understand the French language
- Pregnant or breast feeding females
- Refusal of the patient to participate in the study
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 |
|---|---|---|
| standard carePatients coming for preoperative breast assessment will have standard care. | Other | standard care |
| standard care + conversational hypnosisPatients coming for preoperative breast assessment will have standard care with conversational hypnosis | Other | standard care+conversational hypnosis |
Primary outcome
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time frame: Day 1
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
4 secondary outcomes
Compare the pain felt by patients during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time frame: Day 1
Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time frame: Day 1
Evaluate the receptivity of women to conversational hypnosis
Time frame: Day 1
Assess the impact of conversational hypnosis on completion of the examination
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Results not achievable after interim analysis conclusions and recruting difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Results publication: PubMed 36483698Lemoine L, Adam V, Galus X, Siles P, Coulon A, Grenier-Desforges J, Orabona J, Kergastel I, Wagner P, Salleron J, Tosti P, Huin-Schohn C, Merlin JL, Etienne R, Henrot P. Conversational hypnosis versus standard of care to reduce anxiety in patients undergoing marker placement under radiographic control prior to breast cancer surgery: A randomized, multicenter trial. Front Psychol. 2022 Nov 22;13:971232. doi: 10.3389/fpsyg.2022.971232. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
HENROT Philippe, MD principal investigator
Institut de Cancérologie de Lorraine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer, run by Institut de Cancérologie de Lorraine at 7 sites 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 5 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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: Results not achievable after interim analysis conclusions and recruting difficulty). 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?
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis) (time frame: Day 1). 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 NCT02867644, 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 20 Dec 2022.