Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session) [Time frame: 2 months for each patient]

Secondary outcome measures (2)

• Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious") [Time frame: 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). [Time frame: 2 months for each patient]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years at the time of enrollment into the study.
• Patient with localized or metastatic solid malignant tumor.
• 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).
• Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
• Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
• ECOG patient ≤ 2.
• Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
• Patient affiliated to a Social Health Insurance in France.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse

Identifiers

NCT: NCT04513444 · 20 GENE 07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗