Using medical hypnosis to reduce anxiety in patients undergoing radiotherapy for solid tumors

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

This study tests if adding medical hypnosis to music relaxation can help reduce anxiety in patients getting radiotherapy for solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Claudius Regaud (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Toulouse)
• Trial ID: NCT04513444 on ClinicalTrials.gov

What this trial studies

This phase II interventional study evaluates the effectiveness of medical hypnosis combined with music relaxation in managing anxiety for patients receiving radiotherapy for solid tumors. A total of 45 patients will be randomized into two groups: one receiving standard relaxation with music and the other receiving relaxation with music and hypnosis. Each patient will be monitored for two months to assess their anxiety levels during treatment. The study aims to determine if the addition of hypnosis can provide better anxiety management compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with localized or metastatic solid tumors who are moderately to very anxious during their first course of radiotherapy.

Not a fit: Patients with psychiatric disorders requiring medication or those who do not understand French may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce anxiety levels in patients undergoing radiotherapy, improving their overall treatment experience.

How similar studies have performed: Previous studies have shown promising results using hypnosis for anxiety management in various medical settings, suggesting potential success for this approach.

Eligibility criteria

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).

Where this trial is running

Toulouse

• Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Anne DUCASSOU

Conditions Solid Tumor; Radiotherapy; Hypnosis; Anxiety; Music listening