Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy (HYPNOMUSE)

Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

• Arm A (standard): relaxation with music listening during radiotherapy treatment
• Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Other: Relaxation with music listening during radiotherapy treatment:; Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment:

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anne DUCASSOU; Phone Number: 05 31 15 54 15; Email: ducassou.anne@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse - Oncopole
    • Contact: Anne DUCASSOU; Phone Number: 05 31 15 54 15; Email: ducassou.anne@iuct-oncopole.fr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years at the time of enrollment into the study.
2. Patient with localized or metastatic solid malignant tumor.
3. Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
6. ECOG patient ≤ 2.
7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
8. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patient doesn't understand the French language.
2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
3. Patient with hearing problems.
4. Pregnant or breastfeeding women.
5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard arm (A): music listening therapy	Other: Relaxation with music listening during radiotherapy treatment: Music listening (According to the patient's wishes),; Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.
Experimental: Experimental arm (B): music listening and hypnosis therapy	Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment: Music listening (According to the patient's wishes),; Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session,; Self-hypnosis during the 4th and 5th radiotherapy session,; Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)	Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).	2 months for each patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")		2 months for each patient
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).	Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).	2 months for each patient

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Hypnosis; Radiotherapy; Solid Tumor; Music listening
• Other Study ID Numbers: 20 GENE 07

Drug and device information, study documents

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