Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Solid Tumor Clinical Trial

— HYPNOMUSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513444
• Other study ID #: 20 GENE 07
• Status: Recruiting
• Phase: Phase 2
• Start date: December 7, 2020
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Institut Claudius Regaud
• Contact: Anne DUCASSOU
• Phone: 05 31 15 54 15
• Email: ducassou.anne[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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