Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO) (HYMACO)

Randomized, Comparative Pilot Study Evaluating the Effectiveness of autoHYpnosis by Anchoring in the Prevention of Anxiety Related to Wearing the Mask for Radiotherapy of Head and Neck Tumors

HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors.

60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Tumors
• Intervention / Treatment: Other: Standard care; Other: Autohypnosis; Other: Musicotherapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Louis MERLIN, PU PH; Phone Number: +33 (0)3 83 65 60 62; Email: jl.merlin@nancy.unicancer.fr
• Study Contact Backup: Name: Marie-Aude HERMAN; Phone Number: +33 (0)3 83 53 86 68; Email: m.herman@nancy.unicancer.fr

Study Locations

• France
  • Vandoeuvre les nancy, France, 54519
    • Not yet recruiting
    • Institut de Cancérologie de Lorraine
    • Contact: Sophie RENARD, MD; Phone Number: +33 (0)3 83 59 85 34; Email: s.renard@nancy.unicancer.fr
    • Contact: Rémi ETIENNE; Phone Number: +33 (0)3 83 59 40 07; Email: r.etienne@nancy.unicancer.fr
    • Sub-Investigator: Jean-Christophe Faivre, MD
    • Sub-Investigator: Paul Jung, MD
    • Sub-Investigator: Anaïs Stéfani, MD
    • Sub-Investigator: Maria Jolnerovski, MD
  • Vandœuvre-lès-Nancy, France, Vandoeuvre lès Nancy
    • Recruiting
    • Institut de Cancérologie de Lorraine
    • Contact: Sophie RENARD, MD; Phone Number: 0033 038359427; Email: s.renard@nancy.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > or =18
• Patient to receive radiotherapy for a tumor of the head and neck, with a compression mask
• Patient who obtained a score equal to or greater than 56 on the STAI form Y-A questionnaire during the consultation with the radiotherapist before starting treatment
• Patient capable and willing to follow all study procedures in accordance with the protocol
• Patient who understood the study and gave informed consent
• Patient affiliated to a social security system

Exclusion Criteria:

• Contraindication to hypnosis: psychosis, schizophrenia
• Non-French speaking patient
• Significant hearing loss
• Pregnant woman, likely to be, or breastfeeding
• Persons deprived of their liberty or under guardianship (including guardianship)
• Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
• Patient who has already received radiotherapy to the head or neck with a compression mask

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM A : standard care; standard care : Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care	Other: Standard care; Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care
Active Comparator: ARM B : standard care + Autohypnosis; In addition to the standard care, the patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions	Other: Standard care; Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care; Other: Autohypnosis; The patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions
Active Comparator: ARM C : standard care + Musicotherapy; In addition to the standard care, the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions	Other: Standard care; Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care; Other: Musicotherapy; the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety will be assessed by the maximum value obtained on the STAI form Y-A questionnaire (state anxiety) on the following 3 measurements: on the centering scanner, at the first and 5th radiotherapy session.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety will also be assessed by a digital rating scale (0 to 10), in the centering or radiotherapy scanner room, just before making the mask before the centering scan and before fitting the mask before each of the first five radiotherapy sessions	5 weeks
Conduct of radiotherapy session	The good conduct of the centering scanner and radiotherapy session is determined by: no interruption of the session; the absence of vocal intervention by the manipulator during the session	5 weeks
Time required by the hypnopractor for the hypnosis session	The duration of the conditioning hypnosis session will be collected by the hypnopractor manipulator	1 hour
Receptivity of patients to hypnosis	Corresponds to the time difference in minutes between the actual time of making and wearing the compression mask for the centering scanner and wearing a compression mask for the first 5 radiotherapy sessions and the time estimated by the patient	5 weeks
Assessment of the patient's feelings	The patient's feelings will be evaluate a questionnaire composed of 5 questions already used in a previous study	1 hour
Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis	Assesing by the hypnopractor manipulator at the end of the session using a digital rating scale (0 to 10).	1 hour

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Study Chair: Rémi ETIENNE, Institut de Cancérologie de Lorraine; Principal Investigator: RENARD Sophie, MD, Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Radiotherapy; Autohypnosis; 5 points Mask; Anchoring
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2020-A00813-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No