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Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

NCT ID: NCT02867644

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-17

Study Completion Date

2020-10-16

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Keywords

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conversational hypnosis imaging care breast neoplasia anxiety pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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standard care

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

Patients coming for preoperative breast assessment will have standard care.

standard care+conversational hypnosis

Group Type EXPERIMENTAL

standard care + conversational hypnosis

Intervention Type OTHER

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

Interventions

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standard care

Patients coming for preoperative breast assessment will have standard care.

Intervention Type OTHER

standard care + conversational hypnosis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HENROT Philippe, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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CH Bastia

Bastia, , France

Site Status

Chu Bordeaux-Pellegrin

Bordeaux, , France

Site Status

CHRU de Brest

Brest, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

APHM La Timone

Marseille, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36483698 (View on PubMed)

Other Identifiers

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2016-A00232-49

Identifier Type: -

Identifier Source: org_study_id