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Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer (HYCOREMA)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard care
standard care + conversational hypnosis
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CH Bastia
  • Chu Bordeaux-Pellegrin
  • CHRU de Brest
  • Centre Léon Bérard
  • APHM La Timone
  • Centre Paul Strauss
  • Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard care

standard care+conversational hypnosis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Evaluate the receptivity of women to conversational hypnosis
assessment realisation time flet by patient
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.

Full Information

First Posted
August 11, 2016
Last Updated
December 16, 2022
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02867644
Brief Title
Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer
Acronym
HYCOREMA
Official Title
Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Results not achievable after interim analysis conclusions and recruting difficulty
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
Active Comparator
Arm Title
standard care+conversational hypnosis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
Patients coming for preoperative breast assessment will have standard care.
Intervention Type
Other
Intervention Name(s)
standard care + conversational hypnosis
Intervention Description
Patients coming for preoperative breast assessment will have standard care with conversational hypnosis
Primary Outcome Measure Information:
Title
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Description
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
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)
Description
The pain level will be assessed in each group by a visual analog scale from 0 to 10.
Time Frame
Day 1
Title
Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Description
The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.
Time Frame
Day 1
Title
Evaluate the receptivity of women to conversational hypnosis
Description
assessment realisation time flet by patient
Time Frame
Day 1
Title
Assess the impact of conversational hypnosis on completion of the examination
Description
The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HENROT Philippe, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Bastia
City
Bastia
ZIP/Postal Code
20600
Country
France
Facility Name
Chu Bordeaux-Pellegrin
City
Bordeaux
Country
France
Facility Name
CHRU de Brest
City
Brest
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
APHM La Timone
City
Marseille
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut de Cancerologie de Lorraine
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36483698
Citation
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.
Results Reference
result

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Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

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