NCT02867644

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 17, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

3.9 years

First QC Date

August 11, 2016

Last Update Submit

December 16, 2022

Conditions

Breast Cancer

Keywords

conversational hypnosisimagingcarebreast neoplasiaanxietypain

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    Day 1

  • Evaluate the receptivity of women to conversational hypnosis

    Day 1

  • Assess the impact of conversational hypnosis on completion of the examination

    Day 1

Study Arms (2)

standard care

ACTIVE COMPARATOR
Other: standard care

standard care+conversational hypnosis

EXPERIMENTAL
Other: standard care + conversational hypnosis

Interventions

standard careOTHER

Patients coming for preoperative breast assessment will have standard care.

standard care
standard care + conversational hypnosisOTHER

Patients coming for preoperative breast assessment will have standard care with conversational hypnosis

standard care+conversational hypnosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CH Bastia

Bastia, 20600, France

Location

Chu Bordeaux-Pellegrin

Bordeaux, France

Location

CHRU de Brest

Brest, France

Location

Centre Léon Bérard

Lyon, France

Location

APHM La Timone

Marseille, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • 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.

    PMID: 36483698RESULT

MeSH Terms

Conditions

Breast NeoplasmsAnxiety DisordersPain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • HENROT Philippe, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

November 17, 2016

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)