Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Phase 2

Recruiting

• Conditions: Solid Tumor

• Registration Number: NCT04513444
• Lead Sponsor: Institut Claudius Regaud

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-14
• Study Start: 2020-12-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).	2 months for each patient	Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).
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

Trial Locations

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France