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TerminatedNCT02867644HYCOREMAUpdated Dec 20, 2022

Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

An interventional study of standard care and standard care + conversational hypnosis in Breast Cancer, sponsored by Institut de Cancérologie de Lorraine. Terminated at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Supportive care

Why this study was terminated
Results not achievable after interim analysis conclusions and recruting difficulty
Phase
Not applicable
Study type
Interventional
Enrollment
171
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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

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Conditions studied

  • Breast Cancer

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Keywords

  • conversational hypnosis
  • imaging
  • care
  • breast neoplasia
  • anxiety
  • pain
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 171 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
171 participants (actual)

Study arms

  • Active comparator
    standard care

    Other: standard care

  • Experimental
    standard care+conversational hypnosis

    Other: standard care + conversational hypnosis

Interventions

  • Otherstandard care

    Patients coming for preoperative breast assessment will have standard care.

  • Otherstandard care + conversational hypnosis

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

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What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. Evaluate the receptivity of women to conversational hypnosis

    assessment realisation time flet by patient

    Time frame: Day 1

  4. 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.

    Time frame: Day 1

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Study locations

7 sites
  • CH Bastia
    Bastia, 20600, France
  • Chu Bordeaux-Pellegrin
    Bordeaux, France
  • CHRU de Brest
    Brest, France
  • Centre Léon Bérard
    Lyon, France
  • APHM La Timone
    Marseille, France
  • Centre Paul Strauss
    Strasbourg, 67065, France
  • Institut de Cancerologie de Lorraine
    Vandoeuvre Les Nancy, 54519, France
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02867644
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Aug 16, 2016
Start date
Nov 17, 2016
Primary completion
Oct 16, 2020
Completion
Oct 16, 2020
Last update
Dec 20, 2022

Study contacts

HENROT Philippe, MD
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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